Avanafil
- Product NDC
- 31722-442
- 11-digit product format
- 317220442
- Labeler code
- 31722
- Product ID
- 31722-442_46258a47-8730-8397-e063-6394a90a6478
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Avanafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA209266
- Marketing category
- ANDA
- Marketing start
- 2024-06-14
- Substance
- AVANAFIL
- Active strength
- 200 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Avanafil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVANAFIL | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DR5S136IVO |
| Rxcui | 1291306, 1291365, 1291369 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-442-01 | Avanafil | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 31722-442-30 | Avanafil | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-442 | AVANAFIL (AVANAFIL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20241021_1d04e17d-7399-430a-a8bb-fa1912b155e9.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 |
|---|
| 31722-442-01 | 31722044201 | 100 TABLET in 1 BOTTLE (31722-442-01) | 100 tablet | 2024-06-14 | No | No | Current |
| 31722-442-30 | 31722044230 | 30 TABLET in 1 BOTTLE (31722-442-30) | 30 tablet | 2024-06-14 | No | No | Current |