BENZTROPINE MESYLATE
- Product NDC
- 63323-970
- 11-digit product format
- 633230970
- Labeler code
- 63323
- Product ID
- 63323-970_11222231-55b1-48ee-a8f8-3385f1a2eb36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BENZTROPINE MESYLATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA090233
- Marketing category
- ANDA
- Marketing start
- 2011-05-31
- Substance
- BENZTROPINE MESYLATE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BENZTROPINE MESYLATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZTROPINE MESYLATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WMJ8TL7510 |
| Rxcui | 885205 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-970-02 | BENZTROPINE MESYLATE | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 6 |
| 63323-970-02 | BENZTROPINE MESYLATE | 5 in 1 BOX | INJECTION, SOLUTION | 5 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BENZTROPINE MESYLATE | ACTIVE INGREDIENT | WMJ8TL7510 | BENZTROPINE MESYLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| BENZTROPINE | ACTIVE MOIETY | 1NHL2J4X8K | BENZTROPINE MESYLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BENZTROPINE MESYLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BENZTROPINE MESYLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-970 | BENZTROPINE MESYLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241018_b03bd28e-3b44-41e4-9a7e-28b9d7975245.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-970-02 | 63323097002 | 5 VIAL in 1 BOX (63323-970-02) / 2 mL in 1 VIAL | 5 vial | 2011-05-31 | 0000-00-00 | No | No | Current |