Prescription drug · ANDA
Benztropine Mesylate NDC 67046-1675
Benztropine mesylate 2 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1675-3 | 67046167503 | 30 TABLET in 1 BLISTER PACK (67046-1675-3)Marketed from May 7, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Coupler LLC
- 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 67046-1675_513b1ec3-a9e0-4f7b-e063-6394a90a0dc3SPL ID 513b1ec3-a9e0-4f7b-e063-6394a90a0dc3SPL set ID 513b1f4c-d253-6ad7-e063-6394a90a1dabRxCUI 885209UNII 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
N467046167503followed by a unit qualifier and the quantityPackage 67046-1675-03. 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 | ScieGen Pharmaceuticals Inc | 50228-225 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-226 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-227 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | Coupler LLC | 67046-1674 |