oxycodone and acetaminophen
- Product NDC
- 57664-155
- 11-digit product format
- 576640155
- Labeler code
- 57664
- Product ID
- 57664-155_8df48502-9503-4e53-b637-23f035271bf5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxycodone and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090535
- Marketing category
- ANDA
- Marketing start
- 2015-11-02
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57664-155-13 | 2020-09-14 | C162847 | 48780-1 | ab0e2407-2e17-f274-e053-dbdaa90a6471 | 5d7df029-54b5-419f-b0a4-2a1322a00718 |
| 57664-155-88 | 2020-09-14 | C162847 | 48780-1 | ab0e2407-2e17-f274-e053-dbdaa90a6471 | 5d7df029-54b5-419f-b0a4-2a1322a00718 |
| 57664-155-13 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2e17-f274-e053-dbdaa90a6471 | 5d7df029-54b5-419f-b0a4-2a1322a00718 |
| 57664-155-88 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2e17-f274-e053-dbdaa90a6471 | 5d7df029-54b5-419f-b0a4-2a1322a00718 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57664-155-13 | EA - Each | 57664-155 | d336c946-5ae2-4ce1-b3ac-8db164c57a92 | 1 | 2016-07-19 |
| 57664-155-88 | EA - Each | 57664-155 | cde506fc-cdea-43dc-b6e9-fe66d420b5c7 | 1 | 2016-07-19 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049221 | oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 888bdb1b-4061-09e2-e053-2995a90a2423 | 2 |
| 1049221 | acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SCD | 888bdb1b-4061-09e2-e053-2995a90a2423 | 2 |
| 1049221 | APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SY | 888bdb1b-4061-09e2-e053-2995a90a2423 | 2 |