Pirfenidone
- Product NDC
- 0781-2158
- 11-digit product format
- 007812158
- Labeler code
- 0781
- Product ID
- 0781-2158_dec54143-b962-4f6c-a59c-578d93ca1142
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA212600
- Marketing category
- ANDA
- Marketing start
- 2023-01-09
- 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 |
|---|
| 0781-2158-32 | Pirfenidone | 270 in 1 BOTTLE, PLASTIC | CAPSULE | 270 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-2158 | PIRFENIDONE CAPSULE [SANDOZ INC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20230328_945d4337-7d18-4d84-807b-8ae13750c76d.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 |
|---|
| 0781-2158-32 | 00781215832 | 270 CAPSULE in 1 BOTTLE, PLASTIC (0781-2158-32) | 270 capsule | 2023-01-09 | 0000-00-00 | No | No | Current |