Home NDC 70436-147 Dicyclomine Hydrochloride
Product NDC 70436-147
11-digit product format 704360147
Labeler code 70436
Product ID 70436-147_4c2eae9b-279f-0604-e063-6394a90aaf35
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA207076
Marketing category ANDA
Marketing start 2021-09-23
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 20 mg/2mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 A207076-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207076-001 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 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207076-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-11-02 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 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70436-147-80 Dicyclomine Hydrochloride 2 mL in 1 VIAL INJECTION 2 10 70436-147-81 Dicyclomine Hydrochloride 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 10 70436-147-81 Dicyclomine Hydrochloride 5 in 1 BOX INJECTION 5 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-147 DICYCLOMINE HYDROCHLORIDE INJECTION [SLATE RUN PHARMACEUTICALS, LLC] 6 Current NDC, Legacy NDC, 3 package rows 20241226_e20a1ccf-2f3a-4872-811e-d93fb56b8e83.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 70436-147-80 70436014780 2 mL in 1 VIAL (70436-147-80) 2 ml 2021-09-23 No No Current 70436-147-81 70436014781 5 VIAL, SINGLE-DOSE in 1 BOX (70436-147-81) / 2 mL in 1 VIAL, SINGLE-DOSE 2021-09-23 0000-00-00 No No Current