Pirfenidone
- Product NDC
- 46708-480
- 11-digit product format
- 467080480
- Labeler code
- 46708
- Product ID
- 46708-480_5dd2966d-35b0-4a80-a677-bca6f4c69311
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA212708
- Marketing category
- ANDA
- Marketing start
- 2022-06-10
- 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 |
|---|
| 46708-480-71 | Pirfenidone | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 3 |
| 46708-480-90 | Pirfenidone | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-480 | PIRFENIDONE TABLET, COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, 2 package rows | 20230401_6e4f991a-c9e3-4121-97d0-d07954f17336.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-480-71 | 46708048071 | 500 TABLET, COATED in 1 BOTTLE (46708-480-71) | 2022-06-10 | No | No | Current |
| 46708-480-90 | 46708048090 | 90 TABLET, COATED in 1 BOTTLE (46708-480-90) | 2022-06-10 | No | No | Current |