Prescription drug · ANDA
Benztropine Mesylate NDC 11534-168
Benztropine mesylate 1 mg/1 · Tablet · Oral · SUNRISE PHARMACEUTICAL, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11534-168-09 | 1153401680911534016809 | 100 TABLET in 1 BOTTLE (11534-168-09)Marketed from Oct 16, 2024 | |
| 11534-168-10 | 1153401681011534016810 | 1000 TABLET in 1 BOTTLE (11534-168-10)Marketed from Oct 16, 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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- SUNRISE PHARMACEUTICAL, INCNDC labeler code 11534
- 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 11534-168_192d20d2-c01e-4150-beb0-03f8da966accSPL ID 192d20d2-c01e-4150-beb0-03f8da966accSPL set ID 2c988462-ce77-4e99-b98e-8f6ad519e295RxCUI 885209, 885213, 885219UNII WMJ8TL7510UPC 0311534168099, 0311534168105, 0311534169096, 0311534169102, 0311534167108, 0311534167092
- 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
N411534016809followed by a unit qualifier and the quantityPackage 11534-0168-09. 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.
About NDC 11534-168
- What is NDC 11534-168?
- 11534-168 is the product NDC for Benztropine Mesylate, Benztropine mesylate 1 mg/1 tablet, listed with the FDA by SUNRISE PHARMACEUTICAL, INC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Benztropine Mesylate.
- What is the active ingredient?
- Benztropine mesylate.
- Who is the labeler?
- SUNRISE PHARMACEUTICAL, INC, NDC labeler code 11534. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Benztropine Mesylate?
- 55 other product NDCs are listed under this name. See all Benztropine Mesylate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Benztropine Mesylate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-012 | 87441-0012-01 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | Coupler LLC | 67046-0040 | 67046-0040-03 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | Coupler LLC | 67046-1675 | 67046-1675-03 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | Coupler LLC | 67046-1205 | 67046-1205-03 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | Coupler LLC | 67046-1674 | 67046-1674-03 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | Coupler LLC | 67046-0041 | 67046-0041-03 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | QUAGEN PHARMACEUTICALS LLC | 70752-123 | 70752-0123-1070752-0123-11 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | QUAGEN PHARMACEUTICALS LLC | 70752-124 | 70752-0124-1070752-0124-11 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | QUAGEN PHARMACEUTICALS LLC | 70752-125 | 70752-0125-1070752-0125-11 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2594 | 72162-2594-0072162-2594-0172162-2594-02 |
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 2 mg/1 | TabletOral | Marlex PHARMACEUTICAL, INC | 10135-815 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | SUNRISE PHARMACEUTICAL, INC | 11534-167 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | SUNRISE PHARMACEUTICAL, INC | 11534-169 |