hydrocodone bitartrate and acetaminophen
- Product NDC
- 63629-1183
- 11-digit product format
- 636291183
- Labeler code
- 63629
- Product ID
- 63629-1183_f8c55dd3-a7a6-4c34-a799-828c9ebadb91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207509
- Marketing category
- ANDA
- Marketing start
- 2019-06-17
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 300; 10 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 63629-1183_f8c55dd3-a7a6-4c34-a799-828c9ebadb91
- SPL ID
- f8c55dd3-a7a6-4c34-a799-828c9ebadb91
- 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
- 2019-06-17
- Marketing category
- ANDA
- Application number
- ANDA207509
- Pharmacologic classes
- Opioid Agonist [EPC]; Opioid Agonists [MoA]
- DEA schedule
- CII
- Listing expiration
- 2027-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 300 mg/1 |
| HYDROCODONE BITARTRATE | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 856980 |
| Spl Set Id | 1cdeaf5e-5f82-4820-b244-b0ec7a7307e1 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 63629-1183-1 | 100 TABLET in 1 BOTTLE (63629-1183-1) | 2022-11-09 | 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 |
|---|
| 63629-1183-1 | 63629118301 | 100 TABLET in 1 BOTTLE (63629-1183-1) | 100 tablet | 2022-11-09 | No | No | Historical |