NDC 16729-468 – Pirfenidone
Pirfenidone 801 mg/1 · Tablet, Film Coated · Oral
Product NDC16729-468
Product details
- Brand name
- Pirfenidone
- Generic name
- Pirfenidone
- Labeler
- Accord Healthcare Inc.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA212730
- Marketed since
- May 27, 2022
- Listing expires
- December 31, 2026
- Pharmacologic class
- Pyridone
Active ingredients
- Pirfenidone 801 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 16729-468-15 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-468-15) | May 27, 2022 |
Recalls mentioning this NDC
- D-0420-2023 Mar 8, 2023 · Class II
CGMP Deviations: recalling drug products following an FDA inspection. - D-0419-2023 Mar 8, 2023 · Class II
CGMP Deviations: recalling drug products following an FDA inspection.
Other Pirfenidone products
- 16729-467 Pirfenidone 267 mg/1 · Tablet, Film Coated · Accord Healthcare Inc.
- 69238-1640 Pirfenidone 267 mg/1 · Tablet, Film Coated · Amneal Pharmaceuticals NY LLC
- 60219-1641 Pirfenidone 801 mg/1 · Tablet, Film Coated · Amneal Pharmaceuticals NY LLC
- 60219-1640 Pirfenidone 267 mg/1 · Tablet, Film Coated · Amneal Pharmaceuticals NY LLC
- 69238-1641 Pirfenidone 801 mg/1 · Tablet, Film Coated · Amneal Pharmaceuticals NY LLC
- 70954-869 Pirfenidone 267 mg/1 · Tablet, Film Coated · ANI Pharmaceuticals, Inc.
- 70954-870 Pirfenidone 801 mg/1 · Tablet, Film Coated · ANI Pharmaceuticals, Inc.
- 42291-491 Pirfenidone 267 mg/1 · Tablet, Film Coated · AvKARE
- 42291-492 Pirfenidone 801 mg/1 · Tablet, Film Coated · AvKARE
- 31722-872 Pirfenidone 267 mg/1 · Tablet, Film Coated · Camber Pharmaceuticals, Inc.
- 31722-873 Pirfenidone 801 mg/1 · Tablet, Film Coated · Camber Pharmaceuticals, Inc.
- 42385-926 Pirfenidone 801 mg/1 · Tablet, Film Coated · Laurus Labs Limited