Benztropine Mesylate
- Product NDC
- 0143-9233
- 11-digit product format
- 001439233
- Labeler code
- 0143
- Product ID
- 0143-9233_a86273c1-08ac-4b57-a796-24989c8a2842
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benztropine Mesylate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA209442
- Marketing category
- ANDA
- Marketing start
- 2021-10-14
- 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 |
|---|
| 0143-9233-01 | Benztropine Mesylate | 2 mL in 1 VIAL | INJECTION | 2 | | 5 |
| 0143-9233-05 | Benztropine Mesylate | 5 in 1 BOX | INJECTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9233 | BENZTROPINE MESYLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240413_accd7e33-ca6e-46e6-a2ae-20b9bcd8fb89.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 |
|---|
| 0143-9233-01 | 00143923301 | 2 mL in 1 VIAL | 2 ml | | | | | Historical |
| 0143-9233-05 | 00143923305 | 5 VIAL in 1 BOX (0143-9233-05) / 2 mL in 1 VIAL (0143-9233-01) | 5 vial | 2021-10-14 | 0000-00-00 | No | No | Current |