OPANA
- Product NDC
- 63481-613
- 11-digit product format
- 634810613
- Labeler code
- 63481
- Product ID
- 63481-613_73024db7-4992-42d4-96a0-50f6054a70e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxymorphone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Endo Pharmaceuticals Inc.
- Application
- NDA021611
- Marketing category
- NDA
- Marketing start
- 2006-06-26
- Marketing end
- 2020-04-30
- Substance
- OXYMORPHONE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 52f0f025-f368-4487-8f9b-49af2656aeeb | Product name | 3 | 20201015 |
| 3792daf4-c308-47ef-a996-98dc7faa1671 | Product name | 2 | 20150511 |
| 0476a93f-c9eb-691e-8ebf-e5b816d8f47b | Product name | 1 | 20140508 |
| a4b9889e-23ea-ee9f-05f6-4b861fda077b | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63481-613-70 | EA - Each | 63481-613 | 7e9c344b-8e12-45df-931c-9db955fc8ca6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| OXYMORPHONE HYDROCHLORIDE | ACTIVE INGREDIENT | 5Y2EI94NBC | OPANA (OXYMORPHONE HYDROCHLORIDE) TABLET [STAT RX USA LLC] | 1 | |
| OXYMORPHONE | ACTIVE MOIETY | 9VXA968E0C | OPANA (OXYMORPHONE HYDROCHLORIDE) TABLET [STAT RX USA LLC] | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | OPANA (OXYMORPHONE HYDROCHLORIDE) TABLET [STAT RX USA LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OPANA (OXYMORPHONE HYDROCHLORIDE) TABLET [STAT RX USA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OPANA (OXYMORPHONE HYDROCHLORIDE) TABLET [STAT RX USA LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OPANA (OXYMORPHONE HYDROCHLORIDE) TABLET [STAT RX USA LLC] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 977943 | OPANA 10 MG Oral Tablet | PSN | 285e60f8-2404-47d0-a171-a4f075d6f418 | 1 |
| 977942 | oxyMORphone HCl 10 MG Oral Tablet | PSN | 285e60f8-2404-47d0-a171-a4f075d6f418 | 1 |
| 977943 | oxymorphone hydrochloride 10 MG Oral Tablet [Opana] | SBD | 285e60f8-2404-47d0-a171-a4f075d6f418 | 1 |
| 977942 | oxymorphone hydrochloride 10 MG Oral Tablet | SCD | 285e60f8-2404-47d0-a171-a4f075d6f418 | 1 |
| 977943 | Opana 10 MG Oral Tablet | SY | 285e60f8-2404-47d0-a171-a4f075d6f418 | 1 |