Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 63629-2300
- 11-digit product format
- 636292300
- Labeler code
- 63629
- Product ID
- 63629-2300_5a125c87-9b43-49dc-b98d-a8d3c969a05e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202214
- Marketing category
- ANDA
- Marketing start
- 2014-10-06
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 10 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
openFDA Listing Details
- Product ID
- 63629-2300_5a125c87-9b43-49dc-b98d-a8d3c969a05e
- SPL ID
- 5a125c87-9b43-49dc-b98d-a8d3c969a05e
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Hydrocodone Bitartrate and Acetaminophen
- Generic name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2014-10-06
- Marketing category
- ANDA
- Application number
- ANDA202214
- Pharmacologic classes
- Opioid Agonist [EPC]; Opioid Agonists [MoA]
- DEA schedule
- CII
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| HYDROCODONE BITARTRATE | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 856999 |
| Spl Set Id | 9698729e-08d0-483c-b157-5a4061d97065 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 63629-2300-1 | 1000 TABLET in 1 BOTTLE, PLASTIC (63629-2300-1) | 2014-10-06 | No |
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 |
|---|
| 63629-2300-1 | 63629230001 | 1000 TABLET in 1 BOTTLE, PLASTIC (63629-2300-1) | 1000 tablet | 2014-10-06 | No | No | Historical |