Pirfenidone
- Product NDC
- 51407-914
- 11-digit product format
- 514070914
- Labeler code
- 51407
- Product ID
- 51407-914_445b8f7f-9ec4-5f1d-e063-6394a90a098b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA212709
- Marketing category
- ANDA
- Marketing start
- 2023-05-31
- Substance
- PIRFENIDONE
- Active strength
- 801 mg/1
- Pharmacologic classes
- Pyridone [EPC], Pyridones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pirfenidone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PIRFENIDONE | 801 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D7NLD2JX7U |
| Rxcui | 1868014, 1868018 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51407-914-90 | Pirfenidone | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51407-914 | PIRFENIDONE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | Current NDC, 1 package rows | 20240620_1b3261fe-c066-6e86-e063-6294a90a675c.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 |
|---|
| 51407-914-90 | 51407091490 | 90 TABLET in 1 BOTTLE (51407-914-90) | 90 tablet | 2024-04-30 | No | No | Current |