Pirfenidone
- Product NDC
- 42291-491
- 11-digit product format
- 422910491
- Labeler code
- 42291
- Product ID
- 42291-491_485f7ae5-a12f-d7a7-e063-6294a90a75cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA212570
- Marketing category
- ANDA
- Marketing start
- 2023-10-18
- Substance
- PIRFENIDONE
- Active strength
- 267 mg/1
- Pharmacologic classes
- Pyridone [EPC], Pyridones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pirfenidone
- Listing expiration
- 2027-12-31
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 |
|---|
| 42291-491-09 | Pirfenidone | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
| 42291-491-27 | Pirfenidone | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-491 | PIRFENIDONE TABLET, FILM COATED [AVKARE] | 1 | Current NDC, 2 package rows | 20231019_08046b49-a8b3-a78d-e063-6394a90a80fa.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 |
|---|
| 42291-491-09 | 42291049109 | 90 in 1 BOTTLE | | | | | Historical |
| 42291-491-27 | 42291049127 | 3 BOTTLE in 1 CARTON (42291-491-27) / 90 TABLET, FILM COATED in 1 BOTTLE (42291-491-09) | 3 bottle | 2023-10-18 | No | No | Current |