Benztropine Mesylate
- Product NDC
- 31722-220
- 11-digit product format
- 317220220
- Labeler code
- 31722
- Product ID
- 31722-220_c91afeb7-1f26-4fdc-b1d2-4a11f2e6a88b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benztropine mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceutical, Inc.
- Application
- ANDA090294
- Marketing category
- ANDA
- Marketing start
- 2013-08-01
- Marketing end
- 0000-00-00
- Substance
- BENZTROPINE MESYLATE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 31722-220-01 | 2025-02-19 | C162847 | 48780-1 | 9855d018-e8a0-cd31-e053-dbdaa90ab51a | e331d686-80bd-46f8-b34b-64ca1d213b42 |
| 31722-220-10 | 2025-02-19 | C162847 | 48780-1 | 9855d018-e8a0-cd31-e053-dbdaa90ab51a | e331d686-80bd-46f8-b34b-64ca1d213b42 |
| 31722-220-30 | 2025-02-19 | C162847 | 48780-1 | 9855d018-e8a0-cd31-e053-dbdaa90ab51a | e331d686-80bd-46f8-b34b-64ca1d213b42 |
| 31722-220-01 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e8a0-cd31-e053-dbdaa90ab51a | e331d686-80bd-46f8-b34b-64ca1d213b42 |
| 31722-220-10 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e8a0-cd31-e053-dbdaa90ab51a | e331d686-80bd-46f8-b34b-64ca1d213b42 |
| 31722-220-30 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e8a0-cd31-e053-dbdaa90ab51a | e331d686-80bd-46f8-b34b-64ca1d213b42 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 31722-220-01 | EA - Each | 31722-220 | de379ca0-1373-4432-8791-00717e5be6cc | 1 | 2013-08-02 |
| 31722-220-10 | EA - Each | 31722-220 | 8aa7510c-3550-464a-af4f-12284af85054 | 1 | 2013-08-02 |