Home NDC 0406-1236-01 Diphenoxylate Hydrochloride and Atropine Sulfate
Product NDC 0406-1236
Requested package NDC 0406-1236-01
11-digit product format 004061236
Labeler code 0406
Product ID 0406-1236_c7a8d21f-365e-4a00-a7bf-4ee5fc6c2406
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diphenoxylate hydrochloride and atropine sulfate
Dosage form TABLET
Route ORAL
Labeler SpecGx LLC
Application ANDA213335
Marketing category ANDA
Marketing start 2020-10-30
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 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213335-001 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 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 2.5MG;0.025MG TABLET / ORAL AA 2020-10-06 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213335-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-06 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 0406-1236-01 Diphenoxylate Hydrochloride and Atropine Sulfate 100 in 1 BOTTLE TABLET 100 6 0406-1236-10 Diphenoxylate Hydrochloride and Atropine Sulfate 1000 in 1 BOTTLE TABLET 1000 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-1236 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [SPECGX LLC] 5 Current NDC, Legacy NDC, 2 package rows 20230630_24915aa0-1600-44bb-99fc-46529a794124.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 · 3 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 0406-1236-01 00406123601 100 TABLET in 1 BOTTLE (0406-1236-01) 100 tablet 2020-10-30 0000-00-00 No No Current