OXYCODONE HYDROCHLORIDE
- Product NDC
- 72189-095
- 11-digit product format
- 721890095
- Labeler code
- 72189
- Product ID
- 72189-095_36d68732-0635-1380-e063-6394a90a69c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXYCODONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA204021
- Marketing category
- ANDA
- Marketing start
- 2020-06-15
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OXYCODONE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXYCODONE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, C1ENJ2TE6C |
| Rxcui | 1049214, 1049225, 1049621, 1049683 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-095-30 | OXYCODONE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | | 10 |
| 72189-095-60 | OXYCODONE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET | 60 | | 10 |
| 72189-095-90 | OXYCODONE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-095 | OXYCODONE HYDROCHLORIDE TABLET OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX] | 9 | Current NDC, Legacy NDC, 3 package rows | 20231025_a8206207-ad09-83df-e053-2995a90a78b7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72189-095-30 | 72189009530 | 30 TABLET in 1 BOTTLE (72189-095-30) | 30 tablet | 2020-06-15 | 0000-00-00 | No | No | Current |
| 72189-095-60 | 72189009560 | 60 TABLET in 1 BOTTLE (72189-095-60) | 60 tablet | 2020-06-15 | 0000-00-00 | No | No | Current |
| 72189-095-90 | 72189009590 | 90 TABLET in 1 BOTTLE (72189-095-90) | 90 tablet | 2020-06-15 | 0000-00-00 | No | No | Current |