Pirfenidone Capsule, 267 mg
- Product NDC
- 33342-461
- 11-digit product format
- 333420461
- Labeler code
- 33342
- Product ID
- 33342-461_3e8acd31-bbc7-48d5-956d-6cb04cbdc96c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone Capsule, 267 mg
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA212748
- Marketing category
- ANDA
- Marketing start
- 2020-07-20
- 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 Capsule, 267 mg
- 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 |
|---|
| 33342-461-38 | Pirfenidone Capsule, 267 mg | 63 in 1 BLISTER PACK | CAPSULE | 63 | | 1 |
| 33342-461-38 | Pirfenidone Capsule, 267 mg | 1 in 1 CARTON | CAPSULE | 1 | | 1 |
| 33342-461-58 | Pirfenidone Capsule, 267 mg | 270 in 1 BOTTLE | CAPSULE | 270 | | 1 |
| 33342-461-82 | Pirfenidone Capsule, 267 mg | 1 in 1 CARTON | CAPSULE | 1 | | 1 |
| 33342-461-82 | Pirfenidone Capsule, 267 mg | 252 in 1 BLISTER PACK | CAPSULE | 252 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-461 | PIRFENIDONE CAPSULE, 267 MG CAPSULE [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, 5 package rows | 20250406_3e8acd31-bbc7-48d5-956d-6cb04cbdc96c.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 |
|---|
| 33342-461-38 | 33342046138 | 1 BLISTER PACK in 1 CARTON (33342-461-38) / 63 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2020-07-20 | No | No | Historical |
| 33342-461-58 | 33342046158 | 270 CAPSULE in 1 BOTTLE (33342-461-58) | 270 capsule | 2020-07-20 | No | No | Historical |
| 33342-461-82 | 33342046182 | 1 BLISTER PACK in 1 CARTON (33342-461-82) / 252 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2020-07-20 | No | No | Historical |