Prescription drug · ANDA

Benztropine Mesylate NDC 50228-225

Benztropine mesylate .5 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)50228-225Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50228-0225Add 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 NDC11-digit (billing)PackageCopy
50228-225-0150228022501100 TABLET in 1 BOTTLE (50228-225-01)Marketed from Nov 5, 2024
50228-225-10502280225101000 TABLET in 1 BOTTLE (50228-225-10)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 — .5 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040103
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)Histamine Receptor Antagonists (Mechanism)
Identifiers
Product ID 50228-225_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

N450228022501 followed by a unit qualifier and the quantity

Package 50228-0225-01. 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 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)

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
ProductStrengthForm · routeLabelerProduct NDC
Benztropine MesylateBenztropine mesylate .5 mg/1TabletOralCoupler LLC67046-1674
Benztropine MesylateBenztropine mesylate 2 mg/1TabletOralCoupler LLC67046-1675
Benztropine MesylateBenztropine mesylate 2 mg/1TabletOralScieGen Pharmaceuticals Inc50228-227
Benztropine MesylateBenztropine mesylate 1 mg/1TabletOralScieGen Pharmaceuticals Inc50228-226

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Benztropine Mesylate NDC 50228-225 | Med-Code