OXYCODONE AND ACETAMINOPHEN
- Product NDC
- 21695-233
- 11-digit product format
- 216950233
- Labeler code
- 21695
- Product ID
- 21695-233_89f08066-5ea7-4830-ab8f-8c6a04952604
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxycodone hydrochloride and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA040545
- Marketing category
- ANDA
- Marketing start
- 2011-03-08
- 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
- 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 | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-233-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4968-48b1-e053-8cdaa90a720a | OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only |
| 21695-233-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4968-48b1-e053-8cdaa90a720a | OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only |
| 21695-233-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4968-48b1-e053-8cdaa90a720a | OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-233-30 | OXYCODONE AND ACETAMINOPHEN | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 21695-233-60 | OXYCODONE AND ACETAMINOPHEN | 60 in 1 BOTTLE | TABLET | 60 | 2 | |
| 21695-233-90 | OXYCODONE AND ACETAMINOPHEN | 90 in 1 BOTTLE | TABLET | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-233-30 | EA - Each | 21695-233 | 31304a40-64a4-4751-9a99-b26687d184f6 | 1 | 2012-07-24 |
| 21695-233-60 | EA - Each | 21695-233 | e4676202-0275-4a39-9999-37e906b19384 | 1 | 2012-07-24 |
| 21695-233-90 | EA - Each | 21695-233 | ac069851-4f49-4ac7-ba5d-48bc44e89f63 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049225 | oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 29a8d7c5-288e-4305-8d64-42d8158ae4cd | 2 |
| 1049225 | acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SCD | 29a8d7c5-288e-4305-8d64-42d8158ae4cd | 2 |
| 1049225 | APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SY | 29a8d7c5-288e-4305-8d64-42d8158ae4cd | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-233-30 | 21695023330 | 30 in 1 BOTTLE | Historical |
| 21695-233-60 | 21695023360 | 60 in 1 BOTTLE | Historical |
| 21695-233-90 | 21695023390 | 90 in 1 BOTTLE | Historical |