Danazol
- Product NDC
- 0555-0633
- 11-digit product format
- 005550633
- Labeler code
- 0555
- Product ID
- 0555-0633_012ba27f-5410-4461-bc8a-72004ac311a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Danazol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA074582
- Marketing category
- ANDA
- Marketing start
- 1998-06-25
- Substance
- DANAZOL
- Active strength
- 50 mg/1
- Pharmacologic classes
- Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Danazol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DANAZOL | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N29QWW3BUO |
| Rxcui | 197554, 197555, 197556 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0555-0633-02 | Danazol | 100 in 1 BOTTLE | CAPSULE | 100 | | 15 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0555-0633 | DANAZOL CAPSULE [TEVA PHARMACEUTICALS USA, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20250322_e19acee5-ff33-45a5-bbbf-801756bc59b4.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 |
|---|
| 0555-0633-02 | 00555063302 | 100 CAPSULE in 1 BOTTLE (0555-0633-02) | 100 capsule | 1998-06-25 | 0000-00-00 | No | No | Current |