Home NDC 68083-320-10 DICYCLOMINE HYDROCHLORIDE
Product NDC 68083-320
Requested package NDC 68083-320-10
11-digit product format 680830320
Labeler code 68083
Product ID 68083-320_3b7a6d2b-8d0d-45e3-9778-9a9e010aaf42
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Gland Pharma Limited
Application ANDA210979
Marketing category ANDA
Marketing start 2017-12-20
Marketing end 0000-00-00
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 10 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 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A210979-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210979-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RS 2018-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION 2018-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION 2018-07-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION 2018-07-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION 2018-07-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210979-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-07-02 cb3db0bc1861…
Observed Orange Book normalized TE history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68083-320-10 68083032010 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-320-10) > 2 mL in 1 VIAL, SINGLE-DOSE (68083-320-01) 2017-12-20 0000-00-00 No No Current