Prescription drug · ANDA
Benztropine Mesylate NDC 62135-142
Benztropine mesylate 2 mg/1 · Tablet · Oral · Chartwell RX, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-142-01 | 62135014201 | 100 TABLET in 1 BOTTLE, PLASTIC (62135-142-01)Marketed from Apr 30, 2021 | |
| 62135-142-10 | 62135014210 | 1000 TABLET in 1 BOTTLE, PLASTIC (62135-142-10)Marketed from Apr 30, 2021 | |
| 62135-142-18 | 62135014218 | 180 TABLET in 1 BOTTLE, PLASTIC (62135-142-18)Marketed from Mar 7, 2022 | |
| 62135-142-30 | 62135014230 | 30 TABLET in 1 BOTTLE, PLASTIC (62135-142-30)Marketed from Apr 30, 2021 | |
| 62135-142-57 | 62135014257 | 540 TABLET in 1 BOTTLE, PLASTIC (62135-142-57)Marketed from Mar 7, 2022 |
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
- Chartwell RX, LLC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 081265
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 62135-142_458c005f-8842-3916-e063-6294a90a93b1SPL ID 458c005f-8842-3916-e063-6294a90a93b1SPL set ID c002005d-a478-48d4-b345-cb87edcb061fRxCUI 885209, 885213, 885219UNII WMJ8TL7510UPC 0362135142186, 0362135142575, 0362135141189, 0362135144012, 0362135144579, 0362135141578, 0362135144104, 0362135142100, 0362135144180, 0362135142018
- 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
N462135014201followed by a unit qualifier and the quantityPackage 62135-0142-01. 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.
Other NDCs under ANDA 081265
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 | Chartwell RX, LLC. | 62135-141 |
| Benztropine Mesylate | Benztropine mesylate 1 mg/1 | TabletOral | Chartwell RX, LLC. | 62135-144 |