Home NDC 0615-8483 Dicyclomine hydrochloride
Product NDC 0615-8483
11-digit product format 006158483
Labeler code 0615
Product ID 0615-8483_d6f45cf6-4b7c-4248-9cea-614df0a3dc96
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application ANDA040204
Marketing category ANDA
Marketing start 1997-02-28
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 10 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 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 A040204-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040204-001 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 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040204-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 1997-02-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 10 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 991061 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 0615-8483-39 Dicyclomine hydrochloride 30 in 1 BLISTER PACK CAPSULE 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0615-8483 DICYCLOMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] 2 Current NDC, 1 package rows 20240824_a16e7b6b-dbc9-463d-9bde-dba4f25589cf.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 0615-8483-39 00615848339 30 CAPSULE in 1 BLISTER PACK (0615-8483-39) 30 capsule 2023-08-15 No No Current