Prescription drug · ANDA
Benztropine Mesylate NDC 10135-815
Benztropine mesylate 2 mg/1 · Tablet · Oral · Marlex PHARMACEUTICAL, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-815-01 | 10135081501 | 100 TABLET in 1 BOTTLE (10135-815-01)Marketed from Mar 1, 2025 | |
| 10135-815-10 | 10135081510 | 1000 TABLET in 1 BOTTLE (10135-815-10)Marketed from Mar 1, 2025 |
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
- Marlex PHARMACEUTICAL, INC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204713
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 10135-815_31bbcbfa-dc75-99e2-e063-6394a90aa608SPL ID 31bbcbfa-dc75-99e2-e063-6394a90aa608SPL set ID 31bbcbfa-dc74-99e2-e063-6394a90aa608RxCUI 885209, 885213, 885219UNII WMJ8TL7510UPC 0310135815104, 0310135813100
- 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
N410135081501followed by a unit qualifier and the quantityPackage 10135-0815-01. 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 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 204713
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 | Marlex PHARMACEUTICAL, INC | 10135-813 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | Marlex PHARMACEUTICAL, INC | 10135-814 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | SUNRISE PHARMACEUTICAL, INC | 11534-167 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | SUNRISE PHARMACEUTICAL, INC | 11534-168 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | SUNRISE PHARMACEUTICAL, INC | 11534-169 |