Lomotil NDC 0025-0061

NDC codes

FDA NDC Directory

Product NDC (as listed)0025-0061Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00025-0061Add 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
0025-0061-31	00025006131	100 TABLET in 1 BOTTLE (0025-0061-31)Marketed from Sep 15, 1960

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): Lomotil
Generic name (nonproprietary): diphenoxylate hydrochloride and atropine sulfate
Active ingredients: Diphenoxylate hydrochloride — 2.5 mg/1Atropine sulfate — .025 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Pfizer Laboratories Div Pfizer Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 012462
Marketing start: Sep 15, 1960
Listing expires: Dec 31, 2027
DEA schedule: CV
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 0025-0061_69fba82d-8e83-4efb-8c88-5175fda71617SPL ID 69fba82d-8e83-4efb-8c88-5175fda71617SPL set ID f170584a-1072-4fd7-b1dc-6756703483b9RxCUI 1190572, 1190641UNII W24OD7YW48, 03J5ZE7KA5UPC 0300250061319
Pharmacologic class: Anticholinergic; Antidiarrheal; Cholinergic Muscarinic Antagonist

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

N400025006131 followed by a unit qualifier and the quantity

Package 00025-0061-31. 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 23, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Lomotil is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 012462

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

FDA NDC Directory listings under NDA 012462
Product	Strength	Form · route	Labeler	Product NDC
Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	43353-083
Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	59762-1061