Home NDC 82983-428 Glycopyrrolate Oral Solution
Product NDC 82983-428
11-digit product format 829830428
Labeler code 82983
Product ID 82983-428_80036e14-8ef8-4d3e-a6c5-4bfca592dd79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycopyrrolate
Dosage form SOLUTION
Route ORAL
Labeler AJENAT PHARMACEUTICALS LLC
Application ANDA219267
Marketing category ANDA
Marketing start 2025-12-12
Substance GLYCOPYRROLATE
Active strength 1 mg/5mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic 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 A219267-001 GLYCOPYRROLATE GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2025-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219267-001 AA
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 A219267-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2025-10-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219267-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2025-10-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219267-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2025-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219267-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2025-10-27 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219267-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2025-10-27 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 Glycopyrrolate Oral Solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCOPYRROLATE 1 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V92SO9WP2I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 999961 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 82983-428-47 Glycopyrrolate Oral Solution 1 in 1 BOTTLE SOLUTION 1 2 82983-428-47 Glycopyrrolate Oral Solution 473 mL in 1 BOTTLE SOLUTION 473 2
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 82983-428-47 82983042847 1 BOTTLE in 1 BOTTLE (82983-428-47) / 473 mL in 1 BOTTLE 1 bottle 2025-12-12 No No Current