Oxycodone Hydrochloride
- Product NDC
- 64380-261
- 11-digit product format
- 643800261
- Labeler code
- 64380
- Product ID
- 64380-261_226ed432-8e6c-4de6-840c-55c6379f9064
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA077712
- Marketing category
- ANDA
- Marketing start
- 2024-09-10
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxycodone Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 64380-261-01 | Oxycodone Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 5 |
| 64380-261-02 | Oxycodone Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-261 | OXYCODONE HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED] | 3 | Current NDC, 2 package rows | 20250412_f3116ebf-d72c-4e98-aa50-006be4770c86.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 |
|---|
| 64380-261-01 | 64380026101 | 100 TABLET in 1 BOTTLE, PLASTIC (64380-261-01) | 100 tablet | 2024-09-10 | No | No | Historical |
| 64380-261-02 | 64380026102 | 500 TABLET in 1 BOTTLE, PLASTIC (64380-261-02) | 500 tablet | 2024-09-10 | No | No | Historical |