What is NDC 0603-2435?

0603-2435 is the product NDC for Benztropine Mesylate, Benztropine mesylate 2 mg/1 tablet, listed with the FDA by Par Health USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Par Health USA, LLC, NDC labeler code 0603. 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 0603-2435

NDC codes

FDA NDC Directory

Product NDC (as listed)0603-2435Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00603-2435Add 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
0603-2435-21	0060324352100603243521	100 TABLET in 1 BOTTLE, PLASTIC (0603-2435-21)Marketed from Mar 17, 2022
0603-2435-32	0060324353200603243532	1000 TABLET in 1 BOTTLE, PLASTIC (0603-2435-32)Marketed from Mar 17, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Par Health USA, LLCNDC labeler code 0603
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040715
Marketing start: Mar 17, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Antagonists (Mechanism)Histamine Receptor Antagonists (Mechanism)
Identifiers: Product ID 0603-2435_ea6c0338-9f26-4f6b-8a38-dcdcbd01a990SPL ID ea6c0338-9f26-4f6b-8a38-dcdcbd01a990
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

N400603243521 followed by a unit qualifier and the quantity

Package 00603-2435-21. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0603-2435

What is NDC 0603-2435?: 0603-2435 is the product NDC for Benztropine Mesylate, Benztropine mesylate 2 mg/1 tablet, listed with the FDA by Par Health USA, LLC. 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?: Par Health USA, LLC, NDC labeler code 0603. 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 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
Product	Strength	Form · route	Labeler	Product NDC
Benztropine Mesylate	Benztropine mesylate .5 mg/1	TabletOral	Par Health USA, LLC	0603-2433
Benztropine Mesylate	Benztropine mesylate 1 mg/1	TabletOral	Par Health USA, LLC	0603-2434
Benztropine Mesylate	Benztropine mesylate .5 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8222
Benztropine Mesylate	Benztropine mesylate 1 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8223
Benztropine Mesylate	Benztropine mesylate 2 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8478
Benztropine Mesylate	Benztropine mesylate .5 mg/1	TabletOral	Major Pharmaceuticals	0904-7288
Benztropine Mesylate	Benztropine mesylate 1 mg/1	TabletOral	Major Pharmaceuticals	0904-7289
Benztropine Mesylate	Benztropine mesylate 2 mg/1	TabletOral	Major Pharmaceuticals	0904-7290
Benztropine Mesylate	Benztropine mesylate 1 mg/1	TabletOral	A-S Medication Solutions	50090-7017
Benztropine Mesylate	Benztropine mesylate 2 mg/1	TabletOral	DIRECT RX	61919-128
Benztropine Mesylate	Benztropine mesylate 2 mg/1	TabletOral	Coupler LLC	67046-0040
Benztropine Mesylate	Benztropine mesylate 1 mg/1	TabletOral	Coupler LLC	67046-0041
Benztropine Mesylate	Benztropine mesylate .5 mg/1	TabletOral	Coupler LLC	67046-1205
Benztropine Mesylate	Benztropine mesylate .5 mg/1	TabletOral	American Health Packaging	68084-381
Benztropine Mesylate	Benztropine mesylate 1 mg/1	TabletOral	American Health Packaging	68084-388
Benztropine Mesylate	Benztropine mesylate 2 mg/1	TabletOral	American Health Packaging	68084-389
Benztropine Mesylate	Benztropine mesylate 2 mg/1	TabletOral	Bryant Ranch Prepack	72162-1154
Benztropine Mesylate	Benztropine mesylate 1 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-012