NDC 43353-083

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-083Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0083Add 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
43353-083-30	43353008330	30 TABLET in 1 BOTTLE (43353-083-30)Marketed from Jul 13, 2015
43353-083-53	43353008353	60 TABLET in 1 BOTTLE (43353-083-53)Marketed from Jul 14, 2015
43353-083-60	43353008360	90 TABLET in 1 BOTTLE (43353-083-60)Marketed from Jul 13, 2015
43353-083-70	43353008370	120 TABLET in 1 BOTTLE (43353-083-70)Marketed from Jul 13, 2015
43353-083-80	43353008380	180 TABLET in 1 BOTTLE (43353-083-80)Marketed from Aug 15, 2015
43353-083-90	43353008390	240 TABLET in 1 BOTTLE (43353-083-90)Marketed from Jul 27, 2015

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): Diphenoxylate Hydrochloride and Atropine Sulfate
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: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 012462
Marketing start: Feb 27, 2013
Listing expires: Dec 31, 2026
DEA schedule: CV
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 43353-083_a923a016-80b4-4a98-9494-ada455890843SPL ID a923a016-80b4-4a98-9494-ada455890843SPL set ID 59934cee-4e1f-4958-9e97-6de53b39daf3RxCUI 1190572UNII W24OD7YW48, 03J5ZE7KA5
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

N443353008330 followed by a unit qualifier and the quantity

Package 43353-0083-30. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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
Lomotildiphenoxylate hydrochloride and atropine sulfate	Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1	TabletOral	Pfizer Laboratories Div Pfizer Inc	0025-0061
Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	59762-1061

Diphenoxylate Hydrochloride and Atropine Sulfate NDC 43353-083