What is NDC 50228-227?

50228-227 is the product NDC for Benztropine Mesylate, Benztropine mesylate 2 mg/1 tablet, listed with the FDA by ScieGen Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

ScieGen Pharmaceuticals Inc, NDC labeler code 50228. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Benztropine Mesylate NDC 50228-227

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-227Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0227Add 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	Copy
50228-227-01	5022802270150228022701	100 TABLET in 1 BOTTLE (50228-227-01)Marketed from Nov 5, 2024
50228-227-10	5022802271050228022710	1000 TABLET in 1 BOTTLE (50228-227-10)Marketed from Nov 5, 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 — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: ScieGen Pharmaceuticals IncNDC labeler code 50228
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040103
Marketing start: Nov 5, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Antagonists (Mechanism)Histamine Receptor Antagonists (Mechanism)
Identifiers: Product ID 50228-227_380cce0a-91d5-4c6e-80b0-e2b326264727SPL ID 380cce0a-91d5-4c6e-80b0-e2b326264727SPL set ID 1ead16a7-88ed-407d-b25a-0d9a1d9da5efRxCUI 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

N450228022701 followed by a unit qualifier and the quantity

Package 50228-0227-01. 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 Jan 9, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Benztropine mesylate tablets 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.

Full label on DailyMed (opens in a new tab)

About NDC 50228-227

What is NDC 50228-227?: 50228-227 is the product NDC for Benztropine Mesylate, Benztropine mesylate 2 mg/1 tablet, listed with the FDA by ScieGen Pharmaceuticals 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?: ScieGen Pharmaceuticals Inc, NDC labeler code 50228. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Benztropine Mesylate NDCs
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

All 56 Benztropine Mesylate NDCs

Other NDCs under ANDA 040103

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

FDA NDC Directory listings under ANDA 040103
Product	Strength	Form · route	Labeler	Product NDC
Benztropine Mesylate	Benztropine mesylate .5 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-225
Benztropine Mesylate	Benztropine mesylate 1 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-226
Benztropine Mesylate	Benztropine mesylate .5 mg/1	TabletOral	Coupler LLC	67046-1674
Benztropine Mesylate	Benztropine mesylate 2 mg/1	TabletOral	Coupler LLC	67046-1675