OPANA ER
- Product NDC
- 21695-949
- 11-digit product format
- 216950949
- Labeler code
- 21695
- Product ID
- 21695-949_b639732f-8eb2-4592-aca3-86faf7e5360b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxymorphone Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA021610
- Marketing category
- NDA
- Marketing start
- 2006-06-22
- Marketing end
- 0000-00-00
- Substance
- OXYMORPHONE HYDROCHLORIDE
- Active strength
- 10 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-949-60 | OPANA ER | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Oxymorphone Hydrochloride | ACTIVE INGREDIENT | 5Y2EI94NBC | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| Oxymorphone | ACTIVE MOIETY | 9VXA968E0C | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| triacetin | INACTIVE INGREDIENT | XHX3C3X673 | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-949 | OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20110601_b639732f-8eb2-4592-aca3-86faf7e5360b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-949-60 | 21695094960 | 60 in 1 BOTTLE | Historical |