Benztropine Mesylate (benztropine) NDC 69097-832

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-832Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0832Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
69097-832-02	69097083202	30 TABLET in 1 BOTTLE (69097-832-02)Marketed from Jun 29, 2016
69097-832-07	69097083207	100 TABLET in 1 BOTTLE (69097-832-07)Marketed from Jun 29, 2016
69097-832-15	69097083215	1000 TABLET in 1 BOTTLE (69097-832-15)Marketed from Jun 29, 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
Active ingredients: Benztropine mesylate — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Cipla USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090294
Marketing start: Jun 29, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)Histamine Receptor Antagonists (Mechanism)
Identifiers: Product ID 69097-832_3d362141-de53-4949-b9a5-34f2b7bb0e75SPL ID 3d362141-de53-4949-b9a5-34f2b7bb0e75SPL set ID 3d2732f9-b8a9-4e83-91e7-da616ddcb786RxCUI 885209, 885213, 885219UNII WMJ8TL7510UPC 0369097826079, 0369097827076, 0369097832070
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

N469097083202 followed by a unit qualifier and the quantity

Package 69097-0832-02. 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 May 1, 2020.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090294

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090294
Product	Strength	Form · route	Labeler	Product NDC
Benztropine Mesylatebenztropine	Benztropine mesylate 1 mg/1	TabletOral	Cipla USA Inc.	69097-827
Benztropine Mesylatebenztropine	Benztropine mesylate .5 mg/1	TabletOral	Cipla USA Inc.	69097-826