Prescription drug · ANDA
Benztropine Mesylate NDC 70518-2732
Benztropine mesylate .5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-2732-0 | 70518273200 | 30 TABLET in 1 BLISTER PACK (70518-2732-0)Marketed from May 11, 2020 | |
| 70518-2732-4 | 70518273204 | 100 POUCH in 1 BOX (70518-2732-4) / 1 TABLET in 1 POUCH (70518-2732-3)Marketed from Jan 5, 2026 | |
| 70518-2732-5 | 70518273205 | 100 POUCH in 1 BOX (70518-2732-5) / 1 TABLET in 1 POUCH (70518-2732-6)Marketed from Apr 29, 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 — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090168
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70518-2732_57adcb55-77ba-f1b4-e063-6394a90a4cbaSPL ID 57adcb55-77ba-f1b4-e063-6394a90a4cbaSPL set ID 241479dd-91bf-455a-80a1-1bb2d1c8156dRxCUI 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
N470518273200followed by a unit qualifier and the quantityPackage 70518-2732-00. 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, USP 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 090168
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 | Leading Pharma, LLC | 69315-136 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | Leading Pharma, LLC | 69315-137 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | Leading Pharma, LLC | 69315-138 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-502 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0577 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | Proficient Rx LP | 63187-840 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2677 |