Oxycodone and Acetaminophen
- Product NDC
- 50436-2982
- 11-digit product format
- 504362982
- Labeler code
- 50436
- Product ID
- 50436-2982_0d06ed8f-ecbd-4ac9-835b-b35cf31a10fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA201447
- Marketing category
- ANDA
- Marketing start
- 2013-11-27
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 8 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 |
|---|---|---|---|---|---|
| 50436-2982-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3621-a910-e053-dadaa90a0b85 | Oxycodone and Acetaminophen Tablets, USP |
| 50436-2982-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3621-a910-e053-dadaa90a0b85 | Oxycodone and Acetaminophen Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-2982-1 | Oxycodone and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | 17 | |
| 50436-2982-2 | Oxycodone and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-2982-1 | EA - Each | 50436-2982 | 950d98d6-0bb7-462e-9107-21b579dfa570 | 1 | 2017-07-07 |
| 50436-2982-2 | EA - Each | 50436-2982 | 7d1b9ffb-e5f9-41af-91ea-a0f31a99b9b3 | 1 | 2017-07-07 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-2982 | OXYCODONE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES] | 17 | Legacy NDC, 2 package rows | 20190509_8f84a572-a5a9-4c7b-adc5-ad209393befa.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049214 | oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet | PSN | 8f84a572-a5a9-4c7b-adc5-ad209393befa | 17 |
| 1049221 | oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 8f84a572-a5a9-4c7b-adc5-ad209393befa | 17 |
| 1049225 | oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 8f84a572-a5a9-4c7b-adc5-ad209393befa | 17 |
| 1049214 | acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SCD | 8f84a572-a5a9-4c7b-adc5-ad209393befa | 17 |
| 1049221 | acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SCD | 8f84a572-a5a9-4c7b-adc5-ad209393befa | 17 |
| 1049225 | acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SCD | 8f84a572-a5a9-4c7b-adc5-ad209393befa | 17 |
| 1049214 | APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SY | 8f84a572-a5a9-4c7b-adc5-ad209393befa | 17 |
| 1049221 | APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SY | 8f84a572-a5a9-4c7b-adc5-ad209393befa | 17 |
| 1049225 | APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SY | 8f84a572-a5a9-4c7b-adc5-ad209393befa | 17 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-2982-1 | 50436298201 | 30 in 1 BOTTLE | Historical |
| 50436-2982-2 | 50436298202 | 60 in 1 BOTTLE | Historical |