Danazol
- Product NDC
- 62135-475
- 11-digit product format
- 621350475
- Labeler code
- 62135
- Product ID
- 62135-475_241f23e1-4b4b-4adb-e063-6394a90adcc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Danazol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Chartwell RX, LLC.
- Application
- ANDA077246
- Marketing category
- ANDA
- Marketing start
- 2007-04-19
- 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 |
|---|
| 62135-475-60 | Danazol | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-475 | DANAZOL CAPSULE [CHARTWELL RX, LLC.] | 3 | Current NDC, 1 package rows | 20241012_55ad6325-16f6-4f0c-a1dc-734847052d0b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-475-60 | 62135047560 | 60 CAPSULE in 1 BOTTLE (62135-475-60) | 60 capsule | 2023-02-27 | No | No | Historical |