Benztropine Mesylate
- Product NDC
- 31722-219
- 11-digit product format
- 317220219
- Labeler code
- 31722
- Product ID
- 31722-219_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
- 1 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 |
|---|---|---|---|---|---|
| 31722-219-01 | 2025-02-19 | C162847 | 48780-1 | 9855d018-e8a0-cd31-e053-dbdaa90ab51a | e331d686-80bd-46f8-b34b-64ca1d213b42 |
| 31722-219-10 | 2025-02-19 | C162847 | 48780-1 | 9855d018-e8a0-cd31-e053-dbdaa90ab51a | e331d686-80bd-46f8-b34b-64ca1d213b42 |
| 31722-219-30 | 2025-02-19 | C162847 | 48780-1 | 9855d018-e8a0-cd31-e053-dbdaa90ab51a | e331d686-80bd-46f8-b34b-64ca1d213b42 |
| 31722-219-01 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e8a0-cd31-e053-dbdaa90ab51a | e331d686-80bd-46f8-b34b-64ca1d213b42 |
| 31722-219-10 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e8a0-cd31-e053-dbdaa90ab51a | e331d686-80bd-46f8-b34b-64ca1d213b42 |
| 31722-219-30 | 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 |
|---|---|---|---|---|---|
| 31722-219-01 | EA - Each | 31722-219 | bef440f8-38b7-4689-9905-b04d674aaa4a | 1 | 2013-08-02 |
| 31722-219-10 | EA - Each | 31722-219 | bb7e6488-f069-4e2d-a5cd-36eae99ca59e | 1 | 2013-08-02 |