Home NDC 68788-8751 Dicyclomine Hydrochloride
Product NDC 68788-8751
11-digit product format 687888751
Labeler code 68788
Product ID 68788-8751_00f785fd-3c18-4e62-a0c2-18ce7ae30f25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA217916
Marketing category ANDA
Marketing start 2023-09-13
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A217916-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217916-001 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 2026-09-14 22:38:34 2026-08 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217916-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-08-04 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dicyclomine Hydrochloride
Listing expiration 2027-12-31 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 68788-8751-2 Dicyclomine Hydrochloride 20 in 1 BOTTLE, PLASTIC TABLET 20 4 68788-8751-3 Dicyclomine Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET 30 4 68788-8751-6 Dicyclomine Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET 60 4 68788-8751-9 Dicyclomine Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8751 DICYCLOMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.] 3 Current NDC, 4 package rows 20241222_3ee013cc-ab23-40a1-a44d-1d027c63b132.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 · 5 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 68788-8751-2 68788875102 20 TABLET in 1 BOTTLE, PLASTIC (68788-8751-2) 20 tablet 2023-09-13 No No Current 68788-8751-3 68788875103 30 TABLET in 1 BOTTLE, PLASTIC (68788-8751-3) 30 tablet 2024-10-11 No No Current 68788-8751-6 68788875106 60 TABLET in 1 BOTTLE, PLASTIC (68788-8751-6) 60 tablet 2024-10-11 No No Current 68788-8751-9 68788875109 90 TABLET in 1 BOTTLE, PLASTIC (68788-8751-9) 90 tablet 2024-10-11 No No Current