Home NDC 51293-618-00 Diphenoxylate Hydrochloride and Atropine Sulfate
Product NDC 51293-618
Requested package NDC 51293-618-00
11-digit product format 512930618
Labeler code 51293
Product ID 51293-618_df4e0622-3d00-5cec-e053-2a95a90ac345
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form TABLET
Route ORAL
Labeler ECI Pharmaceuticals, LLC
Application ANDA207128
Marketing category ANDA
Marketing start 2020-10-21
Marketing end 0000-00-00
Substance ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Active strength 0 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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207128-001 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 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207128-001 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG TABLET / ORAL AA 2020-10-21 a50c72e98297…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 51293-618-01 2022-03-29 Diphenoxylate hydrochloride and atropine sulfate tablets, for oral use, C-V 51293-618-10 2022-03-29 Diphenoxylate hydrochloride and atropine sulfate tablets, for oral use, C-V 51293-618-64 2022-03-29 Diphenoxylate hydrochloride and atropine sulfate tablets, for oral use, C-V 51293-618-01 2022-01-28 Diphenoxylate hydrochloride and atropine sulfate tablets, for oral use, C-V 51293-618-10 2022-01-28 Diphenoxylate hydrochloride and atropine sulfate tablets, for oral use, C-V 51293-618-64 2022-01-28 Diphenoxylate hydrochloride and atropine sulfate tablets, for oral use, C-V
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51293-618-00 51293061800 1 BAG in 1 DRUM (51293-618-00) > 1 BAG in 1 BAG > 125000 TABLET in 1 BAG 1 bag 2022-05-17 0000-00-00 No No Current