Home NDC 67296-1741-1 Dicyclomine
Product NDC 67296-1741
Requested package NDC 67296-1741-1
11-digit product format 672961741
Labeler code 67296
Product ID 67296-1741_d61f6438-c067-ed1f-e053-2995a90a5ff6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine hydrochloride
Dosage form TABLET
Route ORAL
Labeler RedPharm Drug, Inc.
Application ANDA040161
Marketing category ANDA
Marketing start 2020-01-01
Marketing end 0000-00-00
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 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 · 42 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 2026-08-18 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…2022-09-29 23:25 UTC 2022-09 A040161-001 DICYCLOMINE HYDROCHLORIDE 20MG TABLET / ORAL AB 1996-10-01 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67296-1741-1 Dicyclomine 10 in 1 BOTTLE TABLET 10 8 67296-1741-7 Dicyclomine 15 in 1 BOTTLE TABLET 15 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-1741 DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [REDPHARM DRUG, INC.] 8 Legacy NDC, 2 package rows 20240805_a330a08e-0cb6-bc66-e053-2995a90ad9e9.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67296-1741-1 67296174101 10 TABLET in 1 BOTTLE (67296-1741-1) 10 tablet 2020-01-01 0000-00-00 No No Current