Prescription drug · ANDA
Benztropine Mesylate NDC 69315-136
Benztropine mesylate .5 mg/1 · Tablet · Oral · Leading Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-136-01 | 6931501360169315013601 | 100 TABLET in 1 BOTTLE (69315-136-01)Marketed from May 15, 2016 | |
| 69315-136-10 | 6931501361069315013610 | 1000 TABLET in 1 BOTTLE (69315-136-10)Marketed from May 15, 2016 |
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 — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Leading Pharma, LLCNDC labeler code 69315
- 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 69315-136_f61e0118-7898-42cf-9e27-e5f2dabe6ea4SPL ID f61e0118-7898-42cf-9e27-e5f2dabe6ea4SPL set ID fe002ec4-07cb-41ca-a58c-33b3a8682101RxCUI 885209, 885213, 885219UNII WMJ8TL7510UPC 0369315137109, 0369315137017, 0369315138014, 0369315136102, 0369315138106, 0369315136010
- 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
N469315013601followed by a unit qualifier and the quantityPackage 69315-0136-01. 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, 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.
About NDC 69315-136
- What is NDC 69315-136?
- 69315-136 is the product NDC for Benztropine Mesylate, Benztropine mesylate .5 mg/1 tablet, listed with the FDA by Leading Pharma, LLC. 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?
- Leading Pharma, LLC, NDC labeler code 69315. 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 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 1 mg/1 | TabletOral | Proficient Rx LP | 63187-840 |
| 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 | REMEDYREPACK INC. | 70518-0577 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2677 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2732 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-502 |