Prescription drug · ANDA
Benztropine Mesylate NDC 68084-388
Benztropine mesylate 1 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-388-01 | 68084038801 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-388-01) / 1 TABLET in 1 BLISTER PACK (68084-388-11)Marketed from Jan 4, 2010 |
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
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040715
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68084-388_43e32855-d7c9-07e1-e063-6294a90af347SPL ID 43e32855-d7c9-07e1-e063-6294a90af347SPL set ID b7f915a9-cd53-4a74-8ee5-35ee5c5c991eRxCUI 885209, 885213, 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
N468084038801followed by a unit qualifier and the quantityPackage 68084-0388-01. 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 040715
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 2 mg/1 | TabletOral | Coupler LLC | 67046-0040 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | Coupler LLC | 67046-0041 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-7017 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-012 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | American Health Packaging | 68084-381 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | American Health Packaging | 68084-389 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | DIRECT RX | 61919-128 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | Endo USA, Inc. | 0603-2433 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8478 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | Endo USA, Inc. | 0603-2434 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | Endo USA, Inc. | 0603-2435 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8222 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8223 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1154 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7288 |
| Benztropine Mesylate | Benztropine mesylate .5 mg/1 | TabletOral | Coupler LLC | 67046-1205 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7289 |
| Benztropine Mesylate | Benztropine mesylate 2 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7290 |