Pirfenidone
- Product NDC
- 69238-1640
- 11-digit product format
- 692381640
- Labeler code
- 69238
- Product ID
- 69238-1640_08b2264e-d081-4558-9893-0a11d25e7a39
- 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
- 2023-02-28
- 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 | 1868014, 1868018 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1640-8 | Pirfenidone | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 2 |
| 69238-1640-9 | Pirfenidone | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1640 | PIRFENIDONE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] | 2 | Current NDC, 2 package rows | 20230412_a235768d-d26d-4ded-ae75-53e93310ff6a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69238-1640-8 | 69238164008 | 3 BOTTLE, PLASTIC in 1 CARTON (69238-1640-8) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1640-9) | 2023-02-28 | No | No | Current |
| 69238-1640-9 | 69238164009 | 90 in 1 BOTTLE, PLASTIC | | | | Historical |