OXYCODONE HYDROCHLORIDE
- Product NDC
- 10544-599
- 11-digit product format
- 105440599
- Labeler code
- 10544
- Product ID
- 10544-599_4bae713c-47eb-4cdd-b727-3b4ec81825ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxycodone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA076758
- Marketing category
- ANDA
- Marketing start
- 2010-04-06
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 10544-599-02 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-cd38-621f-e053-dbdaa90a74ad | OXYCODONE HYDROCHLORIDE Tablets USP CII 5 mg, 15 mg, & 30 mg Rx only |
| 10544-599-30 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-cd38-621f-e053-dbdaa90a74ad | OXYCODONE HYDROCHLORIDE Tablets USP CII 5 mg, 15 mg, & 30 mg Rx only |
| 10544-599-55 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-cd38-621f-e053-dbdaa90a74ad | OXYCODONE HYDROCHLORIDE Tablets USP CII 5 mg, 15 mg, & 30 mg Rx only |
| 10544-599-60 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-cd38-621f-e053-dbdaa90a74ad | OXYCODONE HYDROCHLORIDE Tablets USP CII 5 mg, 15 mg, & 30 mg Rx only |
| 10544-599-90 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-cd38-621f-e053-dbdaa90a74ad | OXYCODONE HYDROCHLORIDE Tablets USP CII 5 mg, 15 mg, & 30 mg Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-599-02 | OXYCODONE HYDROCHLORIDE | 120 in 1 BOTTLE | TABLET | 120 | | 2 |
| 10544-599-30 | OXYCODONE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 10544-599-55 | OXYCODONE HYDROCHLORIDE | 150 in 1 BOTTLE | TABLET | 150 | | 2 |
| 10544-599-60 | OXYCODONE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 10544-599-90 | OXYCODONE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-599 | OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | Legacy NDC, 5 package rows | 20100825_a7a7ba28-78c5-453e-a101-61c6afa40216.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-599-02 | 10544059902 | 120 in 1 BOTTLE | Historical |
| 10544-599-30 | 10544059930 | 30 in 1 BOTTLE | Historical |
| 10544-599-55 | 10544059955 | 150 in 1 BOTTLE | Historical |
| 10544-599-60 | 10544059960 | 60 in 1 BOTTLE | Historical |
| 10544-599-90 | 10544059990 | 90 in 1 BOTTLE | Historical |