Pirfenidone
- Product NDC
- 0480-3610
- 11-digit product format
- 004803610
- Labeler code
- 0480
- Product ID
- 0480-3610_eb41bb72-1c2a-4c39-80a6-c09f3bf897fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA212759
- Marketing category
- ANDA
- Marketing start
- 2022-05-11
- 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 |
|---|
| 0480-3610-87 | Pirfenidone | 270 in 1 BOTTLE | TABLET, FILM COATED | 270 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-3610 | PIRFENIDONE TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250321_cbbd14a4-b7e6-4147-9314-bb715dfb1a51.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 |
|---|
| 0480-3610-00 | 00480361000 | 29850 TABLET, FILM COATED in 1 BOX (0480-3610-00) | 11-MAY-22 | | | | Current |
| 0480-3610-87 | 00480361087 | 270 TABLET, FILM COATED in 1 BOTTLE (0480-3610-87) | 2022-05-11 | 0000-00-00 | No | No | Current |