
Prescription Drug Name:
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, CIII
ID:
175e43e8-c69d-4ddf-9ae9-ef51dba79a01
Code:
34391-3
DESCRIPTION
id: 12d466d5-3232-4f6e-a0e4-97ca074a6f90
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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5 mg/325 mg | 5 mg | 325 mg |
5 mg/500 mg | 5 mg | 500 mg |
7.5 mg/325 mg | 7.5 mg | 325 mg |
7.5 mg/500 mg | 7.5 mg | 500 mg |
7.5 mg/650 mg | 7.5 mg | 650 mg |
7.5 mg/750 mg | 7.5 mg | 750 mg |
10 mg/325 mg | 10 mg | 325 mg |
10 mg/500 mg | 10 mg | 500 mg |
10 mg/650 mg | 10 mg | 650 mg |
10 mg/660 mg | 10 mg | 660 mg |
10 mg/750 mg | 10 mg | 750 mg |
CLINICAL PHARMACOLOGY
id: 8f404c10-69e9-4477-9b63-66272f6d510f
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
INDICATIONS AND USAGE
id: 865c82e3-44ed-4f01-a95a-29273c73b90b
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
CONTRAINDICATIONS
id: b2bb97ce-96dc-4b94-a93a-b585bbbb659e
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
ADVERSE REACTIONS
id: ebade4d6-9038-4479-8865-24b6bb286dbb
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
DRUG ABUSE AND DEPENDENCE
id: 67c79803-b09c-4018-bf5c-c057af4afdb7
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9
OVERDOSAGE
id: 8501eec3-d0e7-4191-aef2-0d59c1d768fe
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
DOSAGE AND ADMINISTRATION
id: f6764e8f-b85a-4941-ad9b-610ae6b72f23
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
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5 mg/325 mg | One to two tablets every four to six hours | 12 tablets |
5 mg/500 mg | One to two tablets every four to six hours | 8 tablets |
7.5 mg/325 mg | One tablet every four to six hours | 8 tablets |
7.5 mg/500 mg | One tablet every four to six hours | 6 tablets |
7.5 mg/650 mg | One tablet every four to six hours | 6 tablets |
7.5 mg/750 mg | One tablet every four to six hours | 5 tablets |
10 mg/325 mg | One tablet every four to six hours | 6 tablets |
10 mg/500 mg | One tablet every four to six hours | 6 tablets |
10 mg/650 mg | One tablet every four to six hours | 6 tablets |
10 mg/660 mg | One tablet every four to six hours | 6 tablets |
10 mg/750 mg | One tablet every four to six hours | 5 tablets |
HOW SUPPLIED
id: da717037-b7ed-4239-b19c-d860e3e64239
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
See |
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5 mg/325 mg | Bottles of 100 ……… NDC 0406-0365-01 Bottles of 500 ……… NDC 0406-0365-05 Unit Dose (10 x 10) … NDC 0406-0365-62 |
5 mg | 325 mg | It is available as a capsule-shaped white tablet debossed with M365 on one side and bisected on the other side. |
5 mg/500 mg | Bottles of 90 ….……NDC 0406-0357-09 Bottles of 100 ….……NDC 0406-0357-01 Bottles of 500 …….…NDC 0406-0357-05 Unit Dose (10 x 10) .….NDC 0406-0357-62 |
5 mg | 500 mg | It is available as a capsule-shaped white tablet debossed with M357 on one side and bisected on the other side. |
7.5 mg/325 mg | Bottles of 100 …….…NDC 0406-0366-01 Bottles of 500 …….…NDC 0406-0366-05 Unit Dose (10 x 10) ….NDC 0406-0366-62 |
7.5 mg | 325 mg | It is available as an unscored oval-shaped white tablet debossed with M366 on one side. |
7.5 mg/500 mg | Bottles of 100 …….…NDC 0406-0358-01 Bottles of 500 …….…NDC 0406-0358-05 Unit Dose (10 x 10) …..NDC 0406-0358-62 |
7.5 mg | 500 mg | It is available as a capsule-shaped white tablet debossed with M358 on one side and bisected on the other side. |
7.5 mg/650 mg | Bottles of 100 ……… NDC 0406-0359-01 Bottles of 500 ……… NDC 0406-0359-05 |
7.5 mg | 650 mg | It is available as a capsule-shaped white tablet debossed with M359 on one side and bisected on the other side. |
7.5 mg/750 mg | Bottles of 90 ….……NDC 0406-0360-09 Bottles of 100 ……… NDC 0406-0360-01 Bottles of 500 ……… NDC 0406-0360-05 |
7.5 mg | 750 mg | It is available as a capsule-shaped white tablet debossed with M360 on one side and bisected on the other side. |
10 mg/325 mg | Bottles of 100 …….… NDC 0406-0367-01 Bottles of 500 ….…… NDC 0406-0367-05 Unit Dose (10 x 10) ….. NDC 0406-0367-62 |
10 mg | 325 mg | It is available as a capsule-shaped white tablet debossed with M367 on one side and bisected on the other side. |
10 mg/500 mg | Bottles of 100 …….… NDC 0406-0363-01 Bottles of 500 ……… NDC 0406-0363-05 Unit Dose (10 x 10) …. NDC 0406-0363-62 |
10 mg | 500 mg | It is available as a capsule-shaped white tablet debossed with M363 on one side and bisected on the other side. |
10 mg/650 mg | Bottles of 100 ……..…NDC 0406-0361-01 Bottles of 500 …….… NDC 0406-0361-05 Unit Dose (10 x 10). ….NDC 0406-0361-62 |
10 mg | 650 mg | It is available as a capsule-shaped blue tablet debossed with M361 on one side and bisected on the other side. |
10 mg/660 mg | Bottles of 100 ………. NDC 0406-0362-01 | 10 mg | 660 mg | It is available as a capsule-shaped white tablet debossed with M362 on one side and bisected on the other side. |
10 mg/750 mg | Bottles of 100 ………. NDC 0406-0364-01 | 10 mg | 750 mg | It is available as a capsule-shaped white tablet debossed with M364 on one side and bisected on the other side. |
Repackaging Information
id: 756f8dfd-8c7c-46d3-9d84-02b10d76738b
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Count |
|
|
|
|
|
10 | 67544-023-10 | – | – | – | – |
15 | 67544-023-15 | – | – | – | – |
20 | 67544-023-20 | 67544-024-20 | – | – | – |
25 | 67544-023-25 | – | – | – | – |
26 | – | 67544-024-20 | – | – | – |
28 | 67544-023-28 | 67544-024-28 | – | – | – |
30 | 67544-023-30 | 67544-024-30 | 67544-670-30 | 67544-025-30 | 67544-026-30 |
40 | 67544-023-40 | 67544-024-40 | – | 67544-025-40 | 67544-026-40 |
45 | 67544-023-45 | 67544-024-45 | – | 67544-025-45 | 67544-026-45 |
56 | 67544-023-46 | 67544-024-46 | – | – | – |
50 | 67544-023-50 | 67544-024-50 | – | – | – |
60 | 67544-023-53 | 67544-024-53 | 67544-670-53 | 67544-025-53 | 67544-026-53 |
84 | 67544-023-54 | 67544-024-54 | – | 67544-025-54 | – |
75 | 67544-023-55 | 67544-024-55 | – | – | – |
80 | 67544-023-57 | 67544-024-57 | – | – | – |
90 | 67544-023-60 | 67544-024-60 | 67544-670-60 | 67544-025-60 | 67544-026-60 |
70 | 67544-023-61 | – | – | – | – |
160 | 67544-023-63 | – | – | – | – |
168 | 67544-023-67 | – | – | – | – |
120 | 67544-023-70 | 67544-024-70 | 67544-670-70 | 67544-025-70 | 67544-026-70 |
112 | 67544-023-72 | 67544-024-72 | – | 67544-025-72 | 67544-026-72 |
150 | 67544-023-75 | 67544-024-75 | 67544-670-75 | 67544-025-75 | 67544-026-75 |
140 | 67544-023-77 | – | – | – | – |
180 | 67544-023-80 | 67544-024-80 | 67544-670-80 | 67544-025-80 | 67544-026-80 |
240 | 67544-023-90 | 67544-024-90 | 67544-670-90 | 67544-025-90 | – |
360 | 67544-023-94 | – | – | – | 67544-026-94 |
Count |
|
|
|
30 | 43353-324-30 | 43353-422-30 | – |
60 | 43353-324-53 | 43353-422-53 | 43353-721-53 |
90 | 43353-324-60 | 43353-422-60 | 43353-721-60 |
120 | 43353-324-70 | 43353-422-70 | 43353-721-70 |
150 | – | 43353-422-75 | – |
180 | 43353-324-80 | – | 43353-721-80 |
240 | 43353-324-90 | – | – |
Cookeville, TN 38506
20130501AW
PRINCIPAL DISPLAY PANEL – 5/325mg
id: 3bacc782-9367-410b-a7fb-280c5cba3922
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPAL DISPLAY PANEL – 7.5/750mg
id: 5458ac7e-58fc-4578-b62d-53fa32c9093a
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPAL DISPLAY PANEL – 7.5/325mg
id: cdb390b9-42f3-4e28-9488-0b2d55f310c1
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4