What is NDC 68475-512?

68475-512 is the product NDC for Benztropine Mesylate, Benztropine mesylate 1 mg/mL injection, listed with the FDA by Navinta LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Navinta LLC, NDC labeler code 68475. 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 68475-512

NDC codes

FDA NDC Directory

Product NDC (as listed)68475-512Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68475-0512Add 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
68475-512-02	6847505120268475051202	5 VIAL in 1 CARTON (68475-512-02) / 2 mL in 1 VIAL (68475-512-01)Marketed from Nov 24, 2020

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 — 1 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Navinta LLCNDC labeler code 68475
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091525
Marketing start: Nov 24, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Antagonists (Mechanism)Histamine Receptor Antagonists (Mechanism)
Identifiers: Product ID 68475-512_29929540-0861-42fa-9b0b-6675023ee007SPL ID 29929540-0861-42fa-9b0b-6675023ee007SPL set ID f92fbafa-314d-4449-831f-26108339e6b2RxCUI 885205UNII WMJ8TL7510UPC 0368475512016
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468475051202 followed by a unit qualifier and the quantity

Package 68475-0512-02. 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 Mar 17, 2026.

Indications (excerpt from the label)

INDICATIONS For use as an adjunct in the therapy of all forms of parkinsonism (see DOSAGE AND ADMINISTRATION ). 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 68475-512

What is NDC 68475-512?: 68475-512 is the product NDC for Benztropine Mesylate, Benztropine mesylate 1 mg/mL injection, listed with the FDA by Navinta LLC. 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?: Navinta LLC, NDC labeler code 68475. 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 091525

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

FDA NDC Directory listings under ANDA 091525
Product	Strength	Form · route	Labeler	Product NDC
Benztropine Mesylate	Benztropine mesylate 1 mg/mL	InjectionIntramuscular, Intravenous	Zydus Pharmaceuticals USA Inc.	68382-860