Home NDC 72888-105-30 Dicyclomine hydrochloride
Product NDC 72888-105
Requested package NDC 72888-105-30
11-digit product format 728880105
Labeler code 72888
Product ID 72888-105_57312da9-892d-e23f-e063-6294a90adc76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Advagen Pharma Ltd.,
Application ANDA216515
Marketing category ANDA
Marketing start 2026-07-17
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 10 mg/1
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 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 A216515-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2026-07-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216515-001 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.
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 A216515-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2026-07-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216515-001 DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2026-07-17 caaa826d4ba7…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A216515-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216515-001 AB 1 caaa826d4ba7…
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 2027-12-31 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.
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 Units Marketing start Sample Exclude flag Status 72888-105-30 72888010530 30 CAPSULE in 1 BOTTLE (72888-105-30) 30 capsule 2026-07-17 No No Current