Home NDC 67296-2158 Dicyclomine hydrochloride
Product NDC 67296-2158
11-digit product format 672962158
Labeler code 67296
Product ID 67296-2158_45d267f6-9cad-b5b1-e063-6294a90a982f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Redpharm Drug
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 67296-2158-3 Dicyclomine hydrochloride 30 in 1 BOTTLE CAPSULE 30 3
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 67296-2158-3 67296215803 30 CAPSULE in 1 BOTTLE (67296-2158-3) 30 capsule 2022-08-23 No No Current