What is NDC 76385-101?

76385-101 is the product NDC for Methscopolamine Bromide, Methscopolamine bromide 5 mg/1 tablet, listed with the FDA by Unichem Pharmaceuticals (USA), Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Unichem Pharmaceuticals (USA), Inc., NDC labeler code 76385. 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 76385-101

NDC codes

FDA NDC Directory

Product NDC (as listed)76385-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76385-0101Add 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
76385-101-60	7638501016076385010160	60 TABLET in 1 BOTTLE (76385-101-60)Marketed from Oct 1, 2013

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: Unichem Pharmaceuticals (USA), Inc.NDC labeler code 76385
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200602
Marketing start: Oct 1, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 76385-101_10a9a368-4ddc-4ffc-abfb-605c98fe1d97SPL ID 10a9a368-4ddc-4ffc-abfb-605c98fe1d97SPL set ID 5c74bfb0-c80a-4a86-acd1-1e3a1b20255dRxCUI 314088, 403914UNII RTN51LK7WLUPC 0376385100018, 0376385101602
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

N476385010160 followed by a unit qualifier and the quantity

Package 76385-0101-60. 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 Dec 10, 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 76385-101

What is NDC 76385-101?: 76385-101 is the product NDC for Methscopolamine Bromide, Methscopolamine bromide 5 mg/1 tablet, listed with the FDA by Unichem Pharmaceuticals (USA), Inc.. It has 1 package NDC, 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?: Unichem Pharmaceuticals (USA), Inc., NDC labeler code 76385. 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 5 mg/1	TabletOral	i3 Pharmaceuticals, LLC	72319-030	72319-0030-0272319-0030-06
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	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	Unichem Pharmaceuticals (USA), Inc.	76385-100	76385-0100-01
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 200602

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

FDA NDC Directory listings under ANDA 200602
Product	Strength	Form · route	Labeler	Product NDC
Methscopolamine Bromide	Methscopolamine bromide 2.5 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-740
Methscopolamine Bromide	Methscopolamine bromide 5 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-741
Methscopolamine Bromide	Methscopolamine bromide 2.5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2471
Methscopolamine Bromide	Methscopolamine bromide 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2472
Methscopolamine Bromide	Methscopolamine bromide 2.5 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	76385-100