Benztropine Mesylate
- Product NDC
- 43353-580
- 11-digit product format
- 433530580
- Labeler code
- 43353
- Product ID
- 43353-580_492e8cdc-125f-46b9-b95d-3c05ab07fe87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benztropine mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennnessee, LLC
- Application
- ANDA204713
- Marketing category
- ANDA
- Marketing start
- 2017-05-15
- 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
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-580 | BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNNESSEE, LLC] | 2 | Legacy NDC | 20221221_262711f1-3ac4-4b85-a550-f16d1db3fba9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-580-30 | 43353058030 | 30 TABLET in 1 BOTTLE, PLASTIC (43353-580-30) | 30 tablet | 2017-07-25 | 0000-00-00 | No | No | Current |
| 43353-580-53 | 43353058053 | 60 TABLET in 1 BOTTLE, PLASTIC (43353-580-53) | 60 tablet | 2017-07-25 | 0000-00-00 | No | No | Current |