Pirfenidone
- Product NDC
- 60505-4681
- 11-digit product format
- 605054681
- Labeler code
- 60505
- Product ID
- 60505-4681_21373a74-fff2-88e4-8a1c-973d94fa05dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA212709
- Marketing category
- ANDA
- Marketing start
- 2024-04-09
- 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 | 1868014, 1868018 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-4681-7 | Pirfenidone | 270 in 1 BOTTLE | TABLET | 270 | | 4 |
| 60505-4681-9 | Pirfenidone | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-4681 | PIRFENIDONE (PIRFENIDONE ) TABLET [APOTEX CORP.] | 3 | Current NDC, 2 package rows | 20240522_9ccfe91e-d1fc-d4c1-115b-dd7859b2c3e6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60505-4681-7 | 60505468107 | 270 TABLET in 1 BOTTLE (60505-4681-7) | 270 tablet | 2024-04-09 | No | No | Current |
| 60505-4681-9 | 60505468109 | 90 TABLET in 1 BOTTLE (60505-4681-9) | 90 tablet | 2024-04-09 | No | No | Current |