Home NDC 50090-5454-0 Dicyclomine
Product NDC 50090-5454
Requested package NDC 50090-5454-0
11-digit product format 500905454
Labeler code 50090
Product ID 50090-5454_2c3cfba9-854e-4a94-96ee-16614b6433c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine hydrochloride
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA040161
Marketing category ANDA
Marketing start 1996-10-01
Marketing end 0000-00-00
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A040161-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040161-001 AB
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50090-5454-0 2024-01-30 C162847 48780-1 1030e365-0fe3-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950 50090-5454-2 2024-01-30 C162847 48780-1 1030e365-0fe3-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950 50090-5454-8 2024-01-30 C162847 48780-1 1030e365-0fe3-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5454-0 Dicyclomine 30 in 1 BOTTLE TABLET 30 6 50090-5454-2 Dicyclomine 20 in 1 BOTTLE TABLET 20 6 50090-5454-8 Dicyclomine 90 in 1 BOTTLE TABLET 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5454 DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS] 6 Legacy NDC, 3 package rows 20220708_b1db8bc1-2fcc-45c3-b49a-c8968649d5e7.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 50090-5454-0 50090545400 30 TABLET in 1 BOTTLE (50090-5454-0) 30 tablet 2021-01-28 0000-00-00 No No Current