Home NDC 54766-200 Motofen
Product NDC 54766-200
11-digit product format 547660200
Labeler code 54766
Product ID 54766-200_43144b43-adf2-3d58-e063-6394a90a2b81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name difenoxin and atropine sulfate
Dosage form TABLET
Route ORAL
Labeler Sebela Pharmaceuticals Inc.
Application NDA017744
Marketing category NDA
Marketing start 2017-04-11
Marketing end 2028-08-31
Substance ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE
Active strength .025; 1 mg/1; mg/1
Pharmacologic classes Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule CIV
NDC exclude flag No
Current FDA listing Yes 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 54766-200 54766-200-04 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017744-001 MOTOFEN HALF-STRENGTH ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE 0.025MG;0.5MG TABLET / ORAL Approved before 1982 N017744-002 MOTOFEN ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982
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.
Product history page 1 of 3 · 82 observed 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 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N017744-001 MOTOFEN HALF-STRENGTH 0.025MG;0.5MG TABLET / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N017744-002 MOTOFEN 0.025MG;1MG TABLET / ORAL RLD, RS, Approved before 1982 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Motofen Active Ingredients# Ingredient, Strength table Ingredient Strength DIFENOXIN HYDROCHLORIDE .025 mg/1 ATROPINE SULFATE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VQZ63K01IW Internal UNII lookup 03J5ZE7KA5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1190738 Internal RxNorm lookup 1190740 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 54766-200-04 Motofen 4 in 1 BLISTER PACK TABLET 4 4 54766-200-10 Motofen 100 in 1 BOTTLE TABLET 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54766-200 MOTOFEN (DIFENOXIN AND ATROPINE SULFATE) TABLET [SEBELA PHARMACEUTICALS INC.] 2 Current NDC, Legacy NDC, 2 package rows 20181215_4cd3f029-a5e3-5812-e054-00144ff8d46c.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 · 2 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 54766-200-04 54766020004 4 TABLET in 1 BLISTER PACK (54766-200-04) 4 tablet 2017-04-11 0000-00-00 Yes No Current 54766-200-10 54766020010 100 TABLET in 1 BOTTLE (54766-200-10) 100 tablet 2017-04-11 2028-08-31 No No Current