Benztropine Mesylate
- Product NDC
- 0517-0785
- 11-digit product format
- 005170785
- Labeler code
- 0517
- Product ID
- 0517-0785_38afd657-1aed-43d6-aad3-9e75fc025e57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benztropine Mesylate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- American Regent, Inc.
- Application
- ANDA091152
- Marketing category
- ANDA
- Marketing start
- 2011-02-04
- Marketing end
- 0000-00-00
- Substance
- BENZTROPINE MESYLATE
- Active strength
- 1 mg/mL
- 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
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 0517-0785 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0517-0785 | 0517-0785-05 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A091152-001 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG/ML | INJECTABLE / INJECTION | | | 2010-03-29 |
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 INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 1 | |
| BENZTROPINE | ACTIVE MOIETY | 1NHL2J4X8K | BENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 1 | |