Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 71335-2105
- 11-digit product format
- 713352105
- Labeler code
- 71335
- Product ID
- 71335-2105_cb5ff3f5-c6c8-461f-b768-cd916d066e7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA211487
- Marketing category
- ANDA
- Marketing start
- 2018-11-08
- 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
- 71335-2105_cb5ff3f5-c6c8-461f-b768-cd916d066e7c
- SPL ID
- cb5ff3f5-c6c8-461f-b768-cd916d066e7c
- 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
- 2018-11-08
- Marketing category
- ANDA
- Application number
- ANDA211487
- 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 | 5d5fa7bb-6416-48dc-95a0-43ffd84cb595 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2105-1 | 30 TABLET in 1 BOTTLE (71335-2105-1) | 2022-06-06 | No |
| 71335-2105-2 | 20 TABLET in 1 BOTTLE (71335-2105-2) | 2022-06-06 | No |
| 71335-2105-3 | 60 TABLET in 1 BOTTLE (71335-2105-3) | 2022-06-06 | No |
| 71335-2105-4 | 90 TABLET in 1 BOTTLE (71335-2105-4) | 2022-06-06 | No |
| 71335-2105-5 | 120 TABLET in 1 BOTTLE (71335-2105-5) | 2022-06-06 | 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 |
|---|
| 71335-2105-1 | 71335210501 | 30 TABLET in 1 BOTTLE (71335-2105-1) | 30 tablet | 2022-06-06 | No | No | Historical |
| 71335-2105-2 | 71335210502 | 20 TABLET in 1 BOTTLE (71335-2105-2) | 20 tablet | 2022-06-06 | No | No | Historical |
| 71335-2105-3 | 71335210503 | 60 TABLET in 1 BOTTLE (71335-2105-3) | 60 tablet | 2022-06-06 | No | No | Historical |
| 71335-2105-4 | 71335210504 | 90 TABLET in 1 BOTTLE (71335-2105-4) | 90 tablet | 2022-06-06 | No | No | Historical |
| 71335-2105-5 | 71335210505 | 120 TABLET in 1 BOTTLE (71335-2105-5) | 120 tablet | 2022-06-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ® Tablets | Bryant Ranch Prepack | 2025-10-08 | HUMAN PRESCRIPTION DRUG LABEL | 102 |
| ® Tablets | Bryant Ranch Prepack | 2023-10-26 | HUMAN PRESCRIPTION DRUG LABEL | 101 |