Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 63629-5422
- 11-digit product format
- 636295422
- Labeler code
- 63629
- Product ID
- 63629-5422_1960bda9-b48f-4f7a-949a-b9fb8ab1ed67
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA040736
- Marketing category
- ANDA
- Marketing start
- 2010-01-18
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
| NO70W886KK | HYDROCODONE BITARTRATE | 34195-34-1 | HYDROCODONE BITARTRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-5422-0 | 63629542200 | 10 TABLET in 1 BOTTLE (63629-5422-0) | 10 tablet | 2017-07-25 | No | No | Historical |
| 63629-5422-1 | 63629542201 | 30 TABLET in 1 BOTTLE (63629-5422-1) | 30 tablet | 2014-10-06 | No | No | Historical |
| 63629-5422-2 | 63629542202 | 120 TABLET in 1 BOTTLE (63629-5422-2) | 120 tablet | 2014-10-14 | No | No | Historical |
| 63629-5422-3 | 63629542203 | 20 TABLET in 1 BOTTLE (63629-5422-3) | 20 tablet | 2014-10-06 | No | No | Historical |
| 63629-5422-4 | 63629542204 | 60 TABLET in 1 BOTTLE (63629-5422-4) | 60 tablet | 2014-10-06 | No | No | Historical |
| 63629-5422-5 | 63629542205 | 90 TABLET in 1 BOTTLE (63629-5422-5) | 90 tablet | 2014-10-06 | No | No | Historical |
| 63629-5422-6 | 63629542206 | 50 TABLET in 1 BOTTLE (63629-5422-6) | 50 tablet | 2019-12-22 | No | No | Historical |
| 63629-5422-7 | 63629542207 | 40 TABLET in 1 BOTTLE (63629-5422-7) | 40 tablet | 2014-10-23 | No | No | Historical |
| 63629-5422-8 | 63629542208 | 15 TABLET in 1 BOTTLE (63629-5422-8) | 15 tablet | 2014-11-03 | No | No | Historical |
| 63629-5422-9 | 63629542209 | 84 TABLET in 1 BOTTLE (63629-5422-9) | 84 tablet | 2014-12-01 | No | No | Historical |