Home NDC 31722-079-01 Dicyclomine hydrochloride
Product NDC 31722-079
Requested package NDC 31722-079-01
11-digit product format 317220079
Labeler code 31722
Product ID 31722-079_24d1b166-e43d-91de-e063-6394a90ae579
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA217566
Marketing category ANDA
Marketing start 2024-05-07
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 20 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 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 A217566-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217566-001 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 2026-02-19 14:30 UTC 2026-02 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217566-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2024-05-07 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 20 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 991086 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 31722-079-01 Dicyclomine hydrochloride 100 in 1 BOTTLE TABLET 100 1 31722-079-10 Dicyclomine hydrochloride 1000 in 1 BOTTLE TABLET 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-079 DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20241020_0590c805-537e-46d3-9500-f4942c1df2ea.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 · 4 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 31722-079-01 31722007901 100 TABLET in 1 BOTTLE (31722-079-01) 100 tablet 2024-05-07 No No Current