HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Product NDC
- 57664-126
- 11-digit product format
- 576640126
- Labeler code
- 57664
- Product ID
- 57664-126_e4d8d15c-2a44-443d-8b50-e41095925da1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090118
- Marketing category
- ANDA
- Marketing start
- 2009-03-30
- Marketing end
- 2021-08-31
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57664-126-13 | EA - Each | 57664-126 | 8a0de5a2-0741-4c2c-a67b-4af743ac59b1 | 1 | 2012-07-24 |
| 57664-126-88 | EA - Each | 57664-126 | 43a5a1ba-5e07-41ad-a23f-721c5a218ddd | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 857002 | HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 4bdf818e-4951-40dc-bf1b-71ab58a79baa | 15 |
| 857002 | acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SCD | 4bdf818e-4951-40dc-bf1b-71ab58a79baa | 15 |
| 857002 | APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SY | 4bdf818e-4951-40dc-bf1b-71ab58a79baa | 15 |
| 857002 | HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 748a1340-1215-4ea9-ba20-9681aa7ed33d | 6 |
| 857002 | acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SCD | 748a1340-1215-4ea9-ba20-9681aa7ed33d | 6 |
| 857002 | APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SY | 748a1340-1215-4ea9-ba20-9681aa7ed33d | 6 |
| 857002 | HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet | PSN | a46da71a-5fe1-4021-b866-4a806a12efa8 | 1 |
| 857002 | acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SCD | a46da71a-5fe1-4021-b866-4a806a12efa8 | 1 |
| 857002 | APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SY | a46da71a-5fe1-4021-b866-4a806a12efa8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57664-126-08 | 57664012608 | 100 TABLET in 1 BOTTLE (57664-126-08) | 100 tablet | 2009-03-30 | 2021-08-31 | No | No | Current |
| 57664-126-83 | 57664012683 | 30 TABLET in 1 BOTTLE (57664-126-83) | 30 tablet | 2009-03-30 | 2021-08-31 | No | No | Current |
| 57664-126-88 | 57664012688 | 100 TABLET in 1 BOTTLE (57664-126-88) | 100 tablet | 2009-03-30 | 2021-08-31 | No | No | Current |