What is NDC 72319-030?

72319-030 is the product NDC for Methscopolamine Bromide, Methscopolamine bromide 5 mg/1 tablet, listed with the FDA by i3 Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

i3 Pharmaceuticals, LLC, NDC labeler code 72319. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Methscopolamine Bromide?

9 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Methscopolamine Bromide NDC 72319-030 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72319-030Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72319-0030Add 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
72319-030-02	72319003002	60 TABLET in 1 BOTTLE (72319-030-02)Marketed from Dec 18, 2024
72319-030-06	72319003006	1000 TABLET in 1 BOTTLE (72319-030-06)Marketed from Dec 18, 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): Methscopolamine Bromide
Generic name (nonproprietary): methscopolamine bromide
Active ingredients: Methscopolamine bromide — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: i3 Pharmaceuticals, LLCNDC labeler code 72319
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216786
Marketing start: Dec 18, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 72319-030_2ee941f2-7d8c-dd6e-e063-6394a90a0db9SPL ID 2ee941f2-7d8c-dd6e-e063-6394a90a0db9SPL set ID 14c0c030-e96d-4a5e-95ff-02dd78a46be3RxCUI 314088, 403914UNII RTN51LK7WL
Pharmacologic class: Anticholinergic

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

N472319003002 followed by a unit qualifier and the quantity

Package 72319-0030-02. 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 Feb 24, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72319-030

What is NDC 72319-030?: 72319-030 is the product NDC for Methscopolamine Bromide, Methscopolamine bromide 5 mg/1 tablet, listed with the FDA by i3 Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Methscopolamine Bromide.
What is the active ingredient?: Methscopolamine bromide.
Who is the labeler?: i3 Pharmaceuticals, LLC, NDC labeler code 72319. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methscopolamine Bromide?: 9 other product NDCs are listed under this name. See all Methscopolamine Bromide 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 Methscopolamine Bromide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Methscopolamine Bromide	Methscopolamine bromide 2.5 mg/1	TabletOral	i3 Pharmaceuticals, LLC	72319-029	72319-0029-0472319-0029-06
Methscopolamine Bromide	Methscopolamine bromide 2.5 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-740	43063-0740-01
Methscopolamine Bromide	Methscopolamine bromide 5 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-741	43063-0741-60
Methscopolamine Bromide	Methscopolamine bromide 2.5 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	76385-100	76385-0100-01
Methscopolamine Bromide	Methscopolamine bromide 5 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	76385-101	76385-0101-60
Methscopolamine Bromide	Methscopolamine bromide 2.5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2471	72162-2471-01
Methscopolamine Bromide	Methscopolamine bromide 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2472	72162-2472-06
Methscopolamine Bromide	Methscopolamine bromide 2.5 mg/1	TabletOral	Breckenridge Pharmaceutical, Inc.	51991-191	51991-0191-01
Methscopolamine Bromide	Methscopolamine bromide 5 mg/1	TabletOral	Breckenridge Pharmaceutical, Inc.	51991-192	51991-0192-0651991-0192-60

Other NDCs under ANDA 216786

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

FDA NDC Directory listings under ANDA 216786
Product	Strength	Form · route	Labeler	Product NDC
Methscopolamine Bromide	Methscopolamine bromide 2.5 mg/1	TabletOral	i3 Pharmaceuticals, LLC	72319-029