Oxycodone and Acetaminophen
- Product NDC
- 70710-1330
- 11-digit product format
- 707101330
- Labeler code
- 70710
- Product ID
- 70710-1330_d0b7fd0e-5231-4f72-920f-e78d3a96335e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA210079
- Marketing category
- ANDA
- Marketing start
- 2017-12-28
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 10 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70710-1330-1 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a7f0-d8a0-e053-dadaa90a6e4e | Oxycodone and Acetaminophen Tablets, USP CII Revised: August 2020 |
| 70710-1330-5 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a7f0-d8a0-e053-dadaa90a6e4e | Oxycodone and Acetaminophen Tablets, USP CII Revised: August 2020 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70710-1330-1 | Oxycodone and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 8 | |
| 70710-1330-5 | Oxycodone and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70710-1330 | OXYCODONE AND ACETAMINOPHEN TABLET [ZYDUS PHARMACEUTICALS (USA) INC. ] | 8 | Legacy NDC, 2 package rows | 20210113_c50617ea-66b6-43be-b579-b9a3836b73a2.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049214 | oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet | PSN | c50617ea-66b6-43be-b579-b9a3836b73a2 | 8 |
| 1049221 | oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet | PSN | c50617ea-66b6-43be-b579-b9a3836b73a2 | 8 |
| 1049225 | oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | c50617ea-66b6-43be-b579-b9a3836b73a2 | 8 |
| 1049635 | oxyCODONE HCl 2.5 MG / acetaminophen 325 MG Oral Tablet | PSN | c50617ea-66b6-43be-b579-b9a3836b73a2 | 8 |
| 1049214 | acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SCD | c50617ea-66b6-43be-b579-b9a3836b73a2 | 8 |
| 1049635 | acetaminophen 325 MG / oxycodone hydrochloride 2.5 MG Oral Tablet | SCD | c50617ea-66b6-43be-b579-b9a3836b73a2 | 8 |
| 1049221 | acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SCD | c50617ea-66b6-43be-b579-b9a3836b73a2 | 8 |
| 1049225 | acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SCD | c50617ea-66b6-43be-b579-b9a3836b73a2 | 8 |
| 1049214 | APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SY | c50617ea-66b6-43be-b579-b9a3836b73a2 | 8 |
| 1049635 | APAP 325 MG / Oxycodone Hydrochloride 2.5 MG Oral Tablet | SY | c50617ea-66b6-43be-b579-b9a3836b73a2 | 8 |
| 1049221 | APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SY | c50617ea-66b6-43be-b579-b9a3836b73a2 | 8 |
| 1049225 | APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SY | c50617ea-66b6-43be-b579-b9a3836b73a2 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70710-1330-1 | 70710133001 | 100 TABLET in 1 BOTTLE (70710-1330-1) | 100 tablet | 2017-12-28 | 0000-00-00 | No | No | Current |
| 70710-1330-5 | 70710133005 | 500 TABLET in 1 BOTTLE (70710-1330-5) | 500 tablet | 2017-12-28 | 0000-00-00 | No | No | Current |