Oxazepam
- Product NDC
- 0228-2067
- 11-digit product format
- 002282067
- Labeler code
- 0228
- Product ID
- 0228-2067_f191a7db-b292-4119-b144-b25c0555b050
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxazepam
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA072253
- Marketing category
- ANDA
- Marketing start
- 2007-01-02
- Substance
- OXAZEPAM
- Active strength
- 10 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxazepam
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXAZEPAM | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GOW6DWN2A |
| Rxcui | 198057, 198059, 312134 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0228-2067-10 | Oxazepam | 100 in 1 BOTTLE | CAPSULE, GELATIN COATED | 100 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OXAZEPAM | ACTIVE INGREDIENT | 6GOW6DWN2A | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| OXAZEPAM | ACTIVE MOIETY | 6GOW6DWN2A | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 4 | |
| OXAZEPAM | ACTIVE INGREDIENT | 6GOW6DWN2A | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| OXAZEPAM | ACTIVE MOIETY | 6GOW6DWN2A | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] | 3 | |
| OXAZEPAM | ACTIVE INGREDIENT | 6GOW6DWN2A | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| OXAZEPAM | ACTIVE MOIETY | 6GOW6DWN2A | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0228-2067 | OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] | 19 | Current NDC, Legacy NDC, 1 package rows | 20240123_a0d5a4c1-ec79-42e6-8e8f-ae4d144edb43.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0228-2067-10 | 00228206710 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0228-2067-10) | 2007-01-02 | 0000-00-00 | No | No | Current |