NDC codes

FDA NDC Directory
Product NDC (as listed)61919-128Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61919-0128Add 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
61919-128-30619190128306191901283030 TABLET in 1 BOTTLE (61919-128-30)Marketed from Jan 1, 2015

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
DIRECT RXNDC labeler code 61919
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 61919-128_4d3fa8d2-31a0-759a-e063-6294a90a0267SPL ID 4d3fa8d2-31a0-759a-e063-6294a90a0267SPL set ID 9b93035b-34d6-4084-ba73-5dea72f9d124RxCUI 885209UNII 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

N461919012830 followed by a unit qualifier and the quantity

Package 61919-0128-30. 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 & USAGE SECTION 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 61919-128

What is NDC 61919-128?
61919-128 is the product NDC for Benztropine Mesylate, Benztropine mesylate 2 mg/1 tablet, listed with the FDA by DIRECT RX. It has 1 package NDC, 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?
DIRECT RX, NDC labeler code 61919. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Benztropine MesylateBenztropine mesylate 1 mg/1TabletOralUnit Dose Solutions, Inc.87441-01287441-0012-01
Benztropine MesylateBenztropine mesylate 2 mg/1TabletOralCoupler LLC67046-004067046-0040-03
Benztropine MesylateBenztropine mesylate 2 mg/1TabletOralCoupler LLC67046-167567046-1675-03
Benztropine MesylateBenztropine mesylate .5 mg/1TabletOralCoupler LLC67046-120567046-1205-03
Benztropine MesylateBenztropine mesylate .5 mg/1TabletOralCoupler LLC67046-167467046-1674-03
Benztropine MesylateBenztropine mesylate 1 mg/1TabletOralCoupler LLC67046-004167046-0041-03
Benztropine MesylateBenztropine mesylate .5 mg/1TabletOralQUAGEN PHARMACEUTICALS LLC70752-12370752-0123-1070752-0123-11
Benztropine MesylateBenztropine mesylate 1 mg/1TabletOralQUAGEN PHARMACEUTICALS LLC70752-12470752-0124-1070752-0124-11
Benztropine MesylateBenztropine mesylate 2 mg/1TabletOralQUAGEN PHARMACEUTICALS LLC70752-12570752-0125-1070752-0125-11
Benztropine MesylateBenztropine mesylate .5 mg/1TabletOralBryant Ranch Prepack72162-259472162-2594-0072162-2594-0172162-2594-02

All 56 Benztropine Mesylate NDCs

Other NDCs under ANDA 040715

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

FDA NDC Directory listings under ANDA 040715
ProductStrengthForm · routeLabelerProduct NDC
Benztropine MesylateBenztropine mesylate .5 mg/1TabletOralPar Health USA, LLC0603-2433
Benztropine MesylateBenztropine mesylate 1 mg/1TabletOralPar Health USA, LLC0603-2434
Benztropine MesylateBenztropine mesylate 2 mg/1TabletOralPar Health USA, LLC0603-2435
Benztropine MesylateBenztropine mesylate .5 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8222
Benztropine MesylateBenztropine mesylate 1 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8223
Benztropine MesylateBenztropine mesylate 2 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8478
Benztropine MesylateBenztropine mesylate .5 mg/1TabletOralMajor Pharmaceuticals0904-7288
Benztropine MesylateBenztropine mesylate 1 mg/1TabletOralMajor Pharmaceuticals0904-7289
Benztropine MesylateBenztropine mesylate 2 mg/1TabletOralMajor Pharmaceuticals0904-7290
Benztropine MesylateBenztropine mesylate 1 mg/1TabletOralA-S Medication Solutions50090-7017
Benztropine MesylateBenztropine mesylate 2 mg/1TabletOralCoupler LLC67046-0040
Benztropine MesylateBenztropine mesylate 1 mg/1TabletOralCoupler LLC67046-0041
Benztropine MesylateBenztropine mesylate .5 mg/1TabletOralCoupler LLC67046-1205
Benztropine MesylateBenztropine mesylate .5 mg/1TabletOralAmerican Health Packaging68084-381
Benztropine MesylateBenztropine mesylate 1 mg/1TabletOralAmerican Health Packaging68084-388
Benztropine MesylateBenztropine mesylate 2 mg/1TabletOralAmerican Health Packaging68084-389
Benztropine MesylateBenztropine mesylate 2 mg/1TabletOralBryant Ranch Prepack72162-1154
Benztropine MesylateBenztropine mesylate 1 mg/1TabletOralUnit Dose Solutions, Inc.87441-012

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