Benztropine Mesylate
- Product NDC
- 58118-0043
- 11-digit product format
- 581180043
- Labeler code
- 58118
- Product ID
- 58118-0043_b015f234-6744-25d9-e053-2995a90ad82e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benztropine mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale, LLC
- Application
- ANDA090168
- Marketing category
- ANDA
- Marketing start
- 2014-01-31
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BENZTROPINE MESYLATE | ACTIVE INGREDIENT | WMJ8TL7510 | BENZTROPINE MESYLATE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 2 | |
| BENZTROPINE | ACTIVE MOIETY | 1NHL2J4X8K | BENZTROPINE MESYLATE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | BENZTROPINE MESYLATE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 2 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | BENZTROPINE MESYLATE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BENZTROPINE MESYLATE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 2 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | BENZTROPINE MESYLATE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BENZTROPINE MESYLATE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BENZTROPINE MESYLATE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | BENZTROPINE MESYLATE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58118-0043 | BENZTROPINE MESYLATE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 8 | Legacy NDC | 20200925_e388847d-e3e9-4c49-a919-b69f54bf2fdf.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58118-0043-8 | 58118004308 | 30 TABLET in 1 BLISTER PACK (58118-0043-8) | 30 tablet | 2015-09-16 | 0000-00-00 | No | No | Current |