Home NDC 70069-441-05 DICYCLOMINE HYDROCHLORIDE
Product NDC 70069-441
Requested package NDC 70069-441-05
11-digit product format 700690441
Labeler code 70069
Product ID 70069-441_a927b130-5b1b-462f-bb0c-2ea8763487ee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DICYCLOMINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Somerset Therapeutics, LLC
Application ANDA214333
Marketing category ANDA
Marketing start 2024-11-05
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 10 mg/mL
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 43 .
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 A214333-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-11-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214333-001 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.
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 2026-09-14 22:38:34 2026-08 A214333-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-11-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214333-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-11-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214333-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214333-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214333-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214333-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214333-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214333-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214333-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-11-01 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214333-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-11-01 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214333-001 DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-11-01 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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/mL
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 70069-441-01 DICYCLOMINE HYDROCHLORIDE 2 mL in 1 AMPULE INJECTION, SOLUTION 2 5 70069-441-05 DICYCLOMINE HYDROCHLORIDE 5 in 1 CARTON INJECTION, SOLUTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-441 DICYCLOMINE HYDROCHLORIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] 5 Current NDC, 2 package rows 20241106_7ad77f59-e24a-406d-95bf-3d5c6cbc3cbe.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 Sample Exclude flag Status 70069-441-05 70069044105 5 AMPULE in 1 CARTON (70069-441-05) / 2 mL in 1 AMPULE (70069-441-01) 5 ampule 2024-11-05 No No Current