Prescription drug · ANDA
Benztropine Mesylate NDC 50228-227
Benztropine mesylate 2 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-227-01 | 50228022701 | 100 TABLET in 1 BOTTLE (50228-227-01)Marketed from Nov 5, 2024 | |
| 50228-227-10 | 50228022710 | 1000 TABLET in 1 BOTTLE (50228-227-10)Marketed from Nov 5, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Benztropine Mesylate
- Generic name (nonproprietary)
- benztropine mesylate
- Active ingredients
- Benztropine mesylate — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040103
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50228-227_380cce0a-91d5-4c6e-80b0-e2b326264727SPL ID 380cce0a-91d5-4c6e-80b0-e2b326264727SPL set ID 1ead16a7-88ed-407d-b25a-0d9a1d9da5efRxCUI 885209, 885213, 885219UNII WMJ8TL7510
- Pharmacologic class
- Anticholinergic; Antihistamine
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450228022701followed by a unit qualifier and the quantityPackage 50228-0227-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Benztropine mesylate tablets are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS ) due to neuroleptic drugs (e.g., phenothiazines).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040103
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | Coupler LLC | 67046-1674 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | Coupler LLC | 67046-1675 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-225 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-226 |