PIRFENIDONE
- Product NDC
- 16729-468
- 11-digit product format
- 167290468
- Labeler code
- 16729
- Product ID
- 16729-468_462905a9-67d0-513b-e063-6294a90aa9b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PIRFENIDONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA212730
- Marketing category
- ANDA
- Marketing start
- 2022-05-27
- Substance
- PIRFENIDONE
- Active strength
- 801 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 | 801 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 |
|---|
| 16729-468-15 | PIRFENIDONE | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 9 |
| 16729-468-64 | PIRFENIDONE | 270 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 270 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-468 | PIRFENIDONE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241006_fab59395-1c5d-4c64-ba47-34d75736e983.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 |
|---|
| 16729-468-15 | 16729046815 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-468-15) | 2022-05-27 | 0000-00-00 | No | No | Current |
| 16729-468-64 | 16729046864 | 270 in 1 BOTTLE, PLASTIC | | | | | Historical |