Pirfenidone
- Product NDC
- 60219-1642
- 11-digit product format
- 602191642
- Labeler code
- 60219
- Product ID
- 60219-1642_7e3cb259-54a9-45b5-b2c4-3edc4a515d54
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA212569
- Marketing category
- ANDA
- Marketing start
- 2022-01-07
- Substance
- PIRFENIDONE
- Active strength
- 267 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 | 267 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D7NLD2JX7U |
| Rxcui | 1592279 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60219-1642-7 | Pirfenidone | 1 in 1 CARTON | CAPSULE | 1 | | 5 |
| 60219-1642-7 | Pirfenidone | 270 in 1 BOTTLE | CAPSULE | 270 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60219-1642 | PIRFENIDONE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250411_1d4d7aa2-1248-4639-baf5-5e2ae72cbcd8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60219-1642-7 | 60219164207 | 1 BOTTLE in 1 CARTON (60219-1642-7) / 270 CAPSULE in 1 BOTTLE | 1 bottle | 2022-01-07 | 0000-00-00 | No | No | Current |