Pirfenidone
- Product NDC
- 60219-1641
- 11-digit product format
- 602191641
- Labeler code
- 60219
- Product ID
- 60219-1641_0d60ec15-427d-43a3-87f0-d83c33221fe1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA212570
- Marketing category
- ANDA
- Marketing start
- 2022-03-29
- 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 |
|---|
| 60219-1641-9 | Pirfenidone | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 11 |
| 60219-1641-9 | Pirfenidone | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60219-1641 | PIRFENIDONE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250411_94362a07-7c64-42ce-adef-f49585af55d6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60219-1641-9 | 60219164109 | 1 BOTTLE, PLASTIC in 1 CARTON (60219-1641-9) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2022-03-29 | 0000-00-00 | No | No | Current |