Benztropine Mesylate
- Product NDC
- 0143-9729
- 11-digit product format
- 001439729
- Labeler code
- 0143
- Product ID
- 0143-9729_fc9c5b4e-53bf-4166-bc2c-f01f2487e9b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benztropine Mesylate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA090287
- Marketing category
- ANDA
- Marketing start
- 2009-09-01
- 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 |
|---|
| 0143-9729-01 | Benztropine Mesylate | 2 mL in 1 AMPULE | INJECTION | 2 | | 10 |
| 0143-9729-05 | Benztropine Mesylate | 5 in 1 CARTON | INJECTION | 5 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9729 | BENZTROPINE MESYLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240413_95620f40-5ddf-41b8-80a5-f658248f26f0.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 |
|---|
| 0143-9729-01 | 00143972901 | 2 mL in 1 AMPULE | 2 ml | | | | | Historical |
| 0143-9729-05 | 00143972905 | 5 AMPULE in 1 CARTON (0143-9729-05) / 2 mL in 1 AMPULE (0143-9729-01) | 5 ampule | 2009-09-01 | 0000-00-00 | No | No | Current |