NDC 13668-453 – Anagrelide
Anagrelide Hydrochloride Anhydrous .5 mg/1 · Capsule · Oral
Product NDC13668-453
Product details
- Brand name
- Anagrelide
- Generic name
- Anagrelide
- Labeler
- Torrent Pharmaceuticals Limited
- Dosage form
- Capsule
- Route
- Oral
- Marketing category
- ANDA · ANDA209151
- Marketed since
- June 30, 2017
- Listing expires
- December 31, 2027
- Pharmacologic class
- Platelet-reducing Agent
Active ingredients
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 13668-453-01 | 100 CAPSULE in 1 BOTTLE (13668-453-01) | Jun 30, 2017 |
| 13668-453-30 | 30 CAPSULE in 1 BOTTLE (13668-453-30) | Jun 30, 2017 |
Recalls mentioning this NDC
- D-0166-2021 Dec 9, 2020 · Class I
Failed Dissolution Specifications - D-1862-2019 Sep 25, 2019 · Class II
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
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- 70954-881 Anagrelide Hydrochloride 1 mg/1 · Capsule · ANI Pharmaceuticals, Inc.
- 62135-312 Anagrelide Hydrochloride Anhydrous .5 mg/1 · Capsule · Chartwell RX, LLC
- 62135-313 Anagrelide Hydrochloride Anhydrous 1 mg/1 · Capsule · Chartwell RX, LLC
- 13668-462 Anagrelide Hydrochloride Anhydrous 1 mg/1 · Capsule · Torrent Pharmaceuticals Limited