OXYCODONE HYDROCHLORIDE
- Product NDC
- 0121-4827
- 11-digit product format
- 001214827
- Labeler code
- 0121
- Product ID
- 0121-4827_1685138a-dd0b-4e6e-b14d-a1132eef8b34
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXYCODONE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA206914
- Marketing category
- ANDA
- Marketing start
- 2019-04-08
- 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
- 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 | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C1ENJ2TE6C |
| Rxcui | 1049604 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-4827-05 | OXYCODONE HYDROCHLORIDE | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 14 |
| 0121-4827-40 | OXYCODONE HYDROCHLORIDE | 4 in 1 CASE | SOLUTION | 4 | | 14 |
| 0121-4827-40 | OXYCODONE HYDROCHLORIDE | 10 in 1 TRAY | SOLUTION | 10 | | 14 |
| 0121-4827-50 | OXYCODONE HYDROCHLORIDE | 10 in 1 TRAY | SOLUTION | 10 | | 14 |
| 0121-4827-50 | OXYCODONE HYDROCHLORIDE | 5 in 1 CASE | SOLUTION | 5 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-4827 | OXYCODONE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 13 | Current NDC, Legacy NDC, 5 package rows | 20240704_73b063b5-24b7-40bf-bc2a-c0e1bfaf61d1.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 |
|---|
| 0121-4827-05 | 00121482705 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 0121-4827-40 | 00121482740 | 4 TRAY in 1 CASE (0121-4827-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4827-05) | 4 tray | 2019-04-10 | 0000-00-00 | No | No | Current |
| 0121-4827-50 | 00121482750 | 5 TRAY in 1 CASE (0121-4827-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4827-05) | 5 tray | 2020-01-10 | 0000-00-00 | No | No | Current |