Oxycodone Hydrochloride
- Product NDC
- 43386-920
- 11-digit product format
- 433860920
- Labeler code
- 43386
- Product ID
- 43386-920_e5a8251c-8fc6-4b34-a01f-1706ebda9f94
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA204603
- Marketing category
- ANDA
- Marketing start
- 2015-04-29
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 20 mg/mL
- 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 | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C1ENJ2TE6C |
| Rxcui | 1049615 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-920-60 | Oxycodone Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 8 |
| 43386-920-60 | Oxycodone Hydrochloride | 30 mL in 1 BOTTLE | SOLUTION | 30 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| BERRY | INACTIVE INGREDIENT | FV3431923Z | OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-920 | OXYCODONE HYDROCHLORIDE SOLUTION [LUPIN PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241204_3eddd18b-695a-4e53-a76c-f6779515b918.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 |
|---|
| 43386-920-60 | 43386092060 | 1 BOTTLE in 1 CARTON (43386-920-60) / 30 mL in 1 BOTTLE | 1 bottle | 2015-04-29 | 0000-00-00 | No | No | Current |