Home NDC 0615-8561 Dicyclomine
Product NDC 0615-8561
11-digit product format 006158561
Labeler code 0615
Product ID 0615-8561_c441cf93-8640-4a93-9be2-86c751358a31
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine hydrochloride
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application ANDA040161
Marketing category ANDA
Marketing start 1996-10-01
Marketing end 2026-05-31
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag No
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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0615-8561-39 Dicyclomine 30 in 1 BLISTER PACK TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0615-8561 DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] 1 Current NDC, 1 package rows 20250223_a48a5b44-3812-4544-82d8-660763d76fd3.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0615-8561-39 00615856139 30 TABLET in 1 BLISTER PACK (0615-8561-39) 30 tablet 2025-02-13 2026-05-31 No No Historical