Home NDC 75826-107 Diphenoxylate Hydrochloride and Atropine Sulfate
Product NDC 75826-107
11-digit product format 758260107
Labeler code 75826
Product ID 75826-107_2b0ecbe9-ac10-5211-e063-6394a90a123e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form TABLET
Route ORAL
Labeler Winder Laboratories LLC
Application ANDA211362
Marketing category ANDA
Marketing start 2022-04-30
Substance ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Active strength .025; 2.5 mg/1; mg/1
Pharmacologic classes Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule CV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211362-001 AA
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211362-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2021-01-27 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Diphenoxylate Hydrochloride and Atropine Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENOXYLATE HYDROCHLORIDE .025 mg/1 ATROPINE SULFATE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W24OD7YW48 Internal UNII lookup 03J5ZE7KA5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1190572 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75826-107-00 Diphenoxylate Hydrochloride and Atropine Sulfate 1000 in 1 BOTTLE, PLASTIC TABLET 1000 9 75826-107-03 Diphenoxylate Hydrochloride and Atropine Sulfate 100 in 1 BOTTLE, PLASTIC TABLET 100 9 75826-107-11 Diphenoxylate Hydrochloride and Atropine Sulfate 10 in 1 BOTTLE, PLASTIC TABLET 10 9 75826-107-33 Diphenoxylate Hydrochloride and Atropine Sulfate 30 in 1 BOTTLE, PLASTIC TABLET 30 9 75826-107-90 Diphenoxylate Hydrochloride and Atropine Sulfate 90 in 1 BOTTLE, PLASTIC TABLET 90 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75826-107 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [WINDER LABORATORIES LLC] 9 Current NDC, Legacy NDC, 5 package rows 20250108_7344a2d2-1f8a-4c5a-90e3-181b919c0c7a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 75826-107-00 75826010700 1000 TABLET in 1 BOTTLE, PLASTIC (75826-107-00) 1000 tablet 2022-09-01 0000-00-00 No No Current 75826-107-03 75826010703 100 TABLET in 1 BOTTLE, PLASTIC (75826-107-03) 100 tablet 2022-09-01 0000-00-00 No No Current 75826-107-10 75826010710 10 TABLET in 1 BOTTLE, PLASTIC (75826-107-10) 10 tablet 2021-02-08 0000-00-00 No No Current 75826-107-11 75826010711 10 TABLET in 1 BOTTLE, PLASTIC (75826-107-11) 10 tablet 2022-09-01 0000-00-00 No No Current 75826-107-20 75826010720 30 TABLET in 1 BOTTLE, PLASTIC (75826-107-20) 30 tablet 2021-02-08 0000-00-00 No No Current 75826-107-30 75826010730 100 TABLET in 1 BOTTLE, PLASTIC (75826-107-30) 100 tablet 2021-02-08 0000-00-00 No No Current 75826-107-33 75826010733 30 TABLET in 1 BOTTLE, PLASTIC (75826-107-33) 30 tablet 2022-09-01 0000-00-00 No No Current 75826-107-40 75826010740 1000 TABLET in 1 BOTTLE, PLASTIC (75826-107-40) 1000 tablet 2021-02-08 0000-00-00 No No Current 75826-107-90 75826010790 90 TABLET in 1 BOTTLE, PLASTIC (75826-107-90) 90 tablet 2022-09-01 0000-00-00 No No Current