Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 21695-268
- 11-digit product format
- 216950268
- Labeler code
- 21695
- Product ID
- 21695-268_b935625d-e9e6-4b5b-a40a-3f4e7f01fa45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA076642
- Marketing category
- ANDA
- Marketing start
- 2009-09-22
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 21695-268-15 | 2022-01-28 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-28 | 2022-01-28 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-30 | 2022-01-28 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-60 | 2022-01-28 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-15 | 2020-07-22 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-28 | 2020-07-22 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-30 | 2020-07-22 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-60 | 2020-07-22 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-15 | 2019-12-12 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-28 | 2019-12-12 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-30 | 2019-12-12 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-60 | 2019-12-12 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-15 | 2019-09-24 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-28 | 2019-09-24 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 21695-268-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-493b-48b1-e053-8cdaa90a720a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-268-15 | Hydrocodone Bitartrate and Acetaminophen | 15 in 1 BOTTLE | TABLET | 15 | | 1 |
| 21695-268-28 | Hydrocodone Bitartrate and Acetaminophen | 28 in 1 BOTTLE | TABLET | 28 | | 1 |
| 21695-268-30 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 21695-268-60 | Hydrocodone Bitartrate and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-268 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 4 package rows | 20101119_b935625d-e9e6-4b5b-a40a-3f4e7f01fa45.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-268-15 | 21695026815 | 15 in 1 BOTTLE | Historical |
| 21695-268-28 | 21695026828 | 28 in 1 BOTTLE | Historical |
| 21695-268-30 | 21695026830 | 30 in 1 BOTTLE | Historical |
| 21695-268-60 | 21695026860 | 60 in 1 BOTTLE | Historical |