Oxycodone Hydrochloride Oral Solution
- Product NDC
- 13107-261
- 11-digit product format
- 131070261
- Labeler code
- 13107
- Product ID
- 13107-261_b0905edb-577e-4e2e-ab2f-c7f5c673b0e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride Oral Solution
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Aurolife Pharma, LLC
- Application
- ANDA212429
- Marketing category
- ANDA
- Marketing start
- 2020-01-27
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- 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 Oral Solution
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXYCODONE HYDROCHLORIDE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C1ENJ2TE6C |
| Rxcui | 1049604, 1049615 |
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 |
|---|
| 13107-261-58 | Oxycodone Hydrochloride Oral Solution | 500 mL in 1 BOTTLE | SOLUTION | 500 | | 3 |
| 13107-261-58 | Oxycodone Hydrochloride Oral Solution | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-261 | OXYCODONE HYDROCHLORIDE ORAL SOLUTION SOLUTION [AUROLIFE PHARMA, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240802_0b3fa92e-8351-4401-860d-4bba8a7155e6.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 |
|---|
| 13107-261-58 | 13107026158 | 1 BOTTLE in 1 CARTON (13107-261-58) / 500 mL in 1 BOTTLE | 1 bottle | 2020-01-27 | 0000-00-00 | No | No | Current |