Home NDC 68071-3782 Dicyclomine
Product NDC 68071-3782
11-digit product format 680713782
Labeler code 68071
Product ID 68071-3782_2eea79bd-1ae0-765d-e063-6294a90a16f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine hydrochloride
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA040161
Marketing category ANDA
Marketing start 1996-10-01
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 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 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 · 43 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 2026-09-14 22:38:34 2026-08 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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
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 68071-3782-3 Dicyclomine 30 in 1 BOTTLE, PLASTIC TABLET 30 2 68071-3782-6 Dicyclomine 60 in 1 BOTTLE, PLASTIC TABLET 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3782 DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [NUCARE PHARMACEUTICALS, INC.] 2 Current NDC, 2 package rows 20250226_2c656550-7e5b-445f-e063-6294a90a8f52.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 68071-3782-3 68071378203 30 TABLET in 1 BOTTLE, PLASTIC (68071-3782-3) 30 tablet 2025-01-23 No No Current 68071-3782-6 68071378206 60 TABLET in 1 BOTTLE, PLASTIC (68071-3782-6) 60 tablet 2025-02-24 No No Current