Diphenoxylate Hydrochloride and Atropine Sulfate

NDC 43353-594 · Aphena Pharma Solutions - Tennessee, LLC

Generic nameDiphenoxylate Hydrochloride and Atropine Sulfate

Dosage formTABLET

RouteORAL

Active ingredient(s)DIPHENOXYLATE HYDROCHLORIDE, ATROPINE SULFATE

Strength.025; 2.5 mg/1; mg/1

Pharmacologic classAnticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]

DEA scheduleCV

Marketing categoryANDA

Packages

43353-594-30 — 30 TABLET in 1 BOTTLE (43353-594-30)

43353-594-53 — 60 TABLET in 1 BOTTLE (43353-594-53)

43353-594-60 — 90 TABLET in 1 BOTTLE (43353-594-60)

43353-594-70 — 120 TABLET in 1 BOTTLE (43353-594-70)

43353-594-80 — 180 TABLET in 1 BOTTLE (43353-594-80)

43353-594-90 — 240 TABLET in 1 BOTTLE (43353-594-90)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

0641-6274 — Atropine Sulfate, 0641-6275 — Atropine Sulfate, 16729-483 — ATROPINE SULFATE, 16729-484 — ATROPINE SULFATE, 16729-512 — Atropine Sulfate, 17856-0125 — Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide, 24208-825 — Atropine Sulfate, 24208-965 — Atropine Sulfate, 42799-826 — Atropine sulfate, 43353-083 — DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE, 50090-3456 — Diphenoxylate Hydrochloride and Atropine Sulfate, 50090-5589 — diphenoxylate hydrochloride and atropine sulfate, 50090-5592 — diphenoxylate hydrochloride and atropine sulfate, 50090-5924 — Atropine Sulfate, 50090-7000 — Atropine Sulfate, 50090-7313 — atropine sulfate, 50742-665 — Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide, 50742-666 — Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide, 50742-667 — Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide, 51662-1207 — ATROPINE SULFATE, +96 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q3 (July 2026 release). All data sources · How to read the labels