Oxycodone Hydrochloride
- Product NDC
- 43386-430
- 11-digit product format
- 433860430
- Labeler code
- 43386
- Product ID
- 43386-430_78c8a4dc-d475-41ca-acf7-9078e9c36c7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA204021
- Marketing category
- ANDA
- Marketing start
- 2017-06-12
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 15 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 | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C1ENJ2TE6C |
| Rxcui | 1049611, 1049618, 1049621, 1049683, 1049686 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-430-01 | Oxycodone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 43386-430-03 | Oxycodone Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 43386-430-05 | Oxycodone Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-430 | OXYCODONE HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240131_801cb437-c189-44f5-83eb-a51c365d8a6b.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 |
|---|
| 43386-430-01 | 43386043001 | 100 TABLET in 1 BOTTLE (43386-430-01) | 100 tablet | 2017-06-12 | 0000-00-00 | No | No | Current |
| 43386-430-03 | 43386043003 | 30 TABLET in 1 BOTTLE (43386-430-03) | 30 tablet | 2017-06-12 | 0000-00-00 | No | No | Current |
| 43386-430-05 | 43386043005 | 500 TABLET in 1 BOTTLE (43386-430-05) | 500 tablet | 2017-06-12 | 0000-00-00 | No | No | Current |