Oxycodone Hydrochloride
- Product NDC
- 13107-055
- 11-digit product format
- 131070055
- Labeler code
- 13107
- Product ID
- 13107-055_a06eea3f-6fd5-4b19-9425-4117a488c676
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurolife Pharma, LLC
- Application
- ANDA202160
- Marketing category
- ANDA
- Marketing start
- 2012-07-12
- 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 | C1ENJ2TE6C |
| Rxcui | 1049611, 1049618, 1049621 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13107-055-01 | Oxycodone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 13107-055-30 | Oxycodone Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 13107-055-99 | Oxycodone Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-055 | OXYCODONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240710_96ad4352-fff3-46a7-85de-466cc161045e.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 |
|---|
| 13107-055-01 | 13107005501 | 100 TABLET in 1 BOTTLE (13107-055-01) | 100 tablet | 2012-07-12 | 0000-00-00 | No | No | Current |
| 13107-055-30 | 13107005530 | 30 TABLET in 1 BOTTLE (13107-055-30) | 30 tablet | 2012-07-12 | 0000-00-00 | No | No | Current |
| 13107-055-99 | 13107005599 | 1000 TABLET in 1 BOTTLE (13107-055-99) | 1000 tablet | 2012-07-12 | 0000-00-00 | No | No | Current |