Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 64850-632
- 11-digit product format
- 648500632
- Labeler code
- 64850
- Product ID
- 64850-632_91acad07-a9ce-450e-b9f6-4401b89bd32c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Elite Laboratories, Inc.
- Application
- ANDA209924
- Marketing category
- ANDA
- Marketing start
- 2018-11-16
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 7.5 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocodone Bitartrate and Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| HYDROCODONE BITARTRATE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 856999, 857002, 857005, 857391 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64850-632-01 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64850-632 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ELITE LABORATORIES, INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20240831_89b8145f-5310-4b58-a65d-586dc90d642d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64850-632-01 | 64850063201 | 100 TABLET in 1 BOTTLE, PLASTIC (64850-632-01) | 100 tablet | 2018-11-16 | No | No | Current |