Home NDC 0517-1980 Dicyclomine hydrochloride
Product NDC 0517-1980
11-digit product format 005171980
Labeler code 0517
Product ID 0517-1980_9ffbe6bb-e13f-48d4-a8e0-55936b5167dd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler American Regent, Inc.
Application ANDA208353
Marketing category ANDA
Marketing start 2017-09-01
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 20 mg/2mL
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 A208353-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208353-001 AP
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 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208353-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-02-17 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 20 mg/2mL
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 991065 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 0517-1980-01 Dicyclomine hydrochloride 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 10 0517-1980-05 Dicyclomine hydrochloride 5 in 1 CARTON INJECTION, SOLUTION 5 10 0517-1980-10 Dicyclomine hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0517-1980 DICYCLOMINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 10 Current NDC, Legacy NDC, 3 package rows 20240130_cab4ecaf-8895-4ae8-add3-233d9cc570a8.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 · 1 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 0517-1980-01 00517198001 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 0517-1980-05 00517198005 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-05) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01) 2017-09-11 0000-00-00 No No Current 0517-1980-10 00517198010 10 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01) 2017-09-11 0000-00-00 No No Current