PIRFENIDONE
- Product NDC
- 76282-715
- 11-digit product format
- 762820715
- Labeler code
- 76282
- Product ID
- 76282-715_2696c9c1-fdbb-4135-862e-ab4cd18ad2aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PIRFENIDONE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- EXELAN PHARMACEUTICALS INC.
- Application
- ANDA212077
- Marketing category
- ANDA
- Marketing start
- 2022-08-02
- 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 | 1592279 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76282-715-27 | PIRFENIDONE | 270 in 1 BOTTLE | CAPSULE | 270 | | 2 |
| 76282-715-90 | PIRFENIDONE | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-715 | PIRFENIDONE CAPSULE [EXELAN PHARMACEUTICALS INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230202_1709582c-9975-4dc1-8181-2501ee670eef.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 |
|---|
| 76282-715-27 | 76282071527 | 270 CAPSULE in 1 BOTTLE (76282-715-27) | 270 capsule | 2022-08-02 | 0000-00-00 | No | No | Current |
| 76282-715-90 | 76282071590 | 90 CAPSULE in 1 BOTTLE (76282-715-90) | 90 capsule | 2022-08-02 | 0000-00-00 | No | No | Current |