Oxycodone Hydrochloride and Acetaminophen
- Product NDC
- 64850-622
- 11-digit product format
- 648500622
- Labeler code
- 64850
- Product ID
- 64850-622_523e66c8-fe6d-48c6-ab88-8c5eb25697b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Elite Laboratories, Inc.
- Application
- ANDA209385
- Marketing category
- ANDA
- Marketing start
- 2017-12-04
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 325; 7.5 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxycodone Hydrochloride and Acetaminophen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| OXYCODONE HYDROCHLORIDE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, C1ENJ2TE6C |
| Rxcui | 1049214, 1049221, 1049225 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64850-622-01 | Oxycodone Hydrochloride and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 16 |
| 64850-622-05 | Oxycodone Hydrochloride and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64850-622 | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET [ELITE LABORATORIES, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240829_27fa8190-d334-4bb9-b277-d1f44db433e3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64850-622-01 | 64850062201 | 100 TABLET in 1 BOTTLE (64850-622-01) | 100 tablet | 2017-12-04 | No | No | Current |
| 64850-622-05 | 64850062205 | 500 TABLET in 1 BOTTLE (64850-622-05) | 500 tablet | 2026-04-09 | No | No | Current |