Home NDC 43547-634 Dicyclomine hydrochloride
Product NDC 43547-634
11-digit product format 435470634
Labeler code 43547
Product ID 43547-634_d0954a7a-812b-487e-8c22-2a2a58303277
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Solco Healthcare US,LLC
Application ANDA217531
Marketing category ANDA
Marketing start 2022-08-23
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
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 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 A217531-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217531-001 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.
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 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217531-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2023-08-30 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Dicyclomine hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICYCLOMINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CQ903KQA31 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 991061 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 43547-634-10 Dicyclomine hydrochloride 100 in 1 BOTTLE CAPSULE 100 1 43547-634-11 Dicyclomine hydrochloride 1000 in 1 BOTTLE CAPSULE 1000 1 43547-634-50 Dicyclomine hydrochloride 500 in 1 BOTTLE CAPSULE 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-634 DICYCLOMINE HYDROCHLORIDE CAPSULE [SOLCO HEALTHCARE US,LLC] 1 Current NDC, 3 package rows 20230831_d0954a7a-812b-487e-8c22-2a2a58303277.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 Sample Exclude flag Status 43547-634-10 43547063410 100 CAPSULE in 1 BOTTLE (43547-634-10) 100 capsule 2022-08-23 No No Current 43547-634-11 43547063411 1000 CAPSULE in 1 BOTTLE (43547-634-11) 1000 capsule 2022-08-23 No No Current 43547-634-50 43547063450 500 CAPSULE in 1 BOTTLE (43547-634-50) 500 capsule 2022-08-23 No No Current