Oxazepam
- Product NDC
- 71610-639
- 11-digit product format
- 716100639
- Labeler code
- 71610
- Product ID
- 71610-639_7aebd188-6319-41ca-950d-352ced2eeb19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA071026
- Marketing category
- ANDA
- Marketing start
- 2021-06-01
- Substance
- OXAZEPAM
- Active strength
- 15 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 | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GOW6DWN2A |
| Rxcui | 312134 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-639-30 | Oxazepam | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 71610-639-53 | Oxazepam | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
| 71610-639-60 | Oxazepam | 90 in 1 BOTTLE | CAPSULE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-639 | OXAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20220311_f1e50d01-f529-4894-97d4-0af680a8b461.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 |
|---|
| 71610-639-30 | 71610063930 | 30 CAPSULE in 1 BOTTLE (71610-639-30) | 30 capsule | 2022-03-09 | 0000-00-00 | No | No | Current |
| 71610-639-53 | 71610063953 | 60 CAPSULE in 1 BOTTLE (71610-639-53) | 60 capsule | 2022-03-09 | 0000-00-00 | No | No | Current |
| 71610-639-60 | 71610063960 | 90 CAPSULE in 1 BOTTLE (71610-639-60) | 90 capsule | 2022-03-09 | 0000-00-00 | No | No | Current |