Pirfenidone
- Product NDC
- 42571-335
- 11-digit product format
- 425710335
- Labeler code
- 42571
- Product ID
- 42571-335_36ba36c4-7b9d-e62c-e063-6394a90acdab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Micro Labs Limited
- Application
- ANDA212680
- Marketing category
- ANDA
- Marketing start
- 2022-12-01
- 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 |
|---|
| 42571-335-39 | Pirfenidone | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 4 |
| 42571-335-90 | Pirfenidone | 90 in 1 CARTON | TABLET, FILM COATED | 90 | | 4 |
| 42571-335-90 | Pirfenidone | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-335 | PIRFENIDONE (PIRFENIDONE) TABLET, FILM COATED [MICRO LABS LIMITED] | 3 | Current NDC, Legacy NDC, 3 package rows | 20240204_1abc06c7-6a45-4a0b-b2da-c228aaa137ed.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 |
|---|
| 42571-335-39 | 42571033539 | 3 TABLET, FILM COATED in 1 CARTON (42571-335-39) | | 2022-12-01 | | No | No | Current |
| 42571-335-90 | 42571033590 | 90 BOTTLE in 1 CARTON (42571-335-90) / 90 TABLET, FILM COATED in 1 BOTTLE | 90 bottle | 2022-12-01 | 0000-00-00 | No | No | Current |