Home NDC 70010-106-44 Glycopyrrolate Oral Solution
Product NDC 70010-106
Requested package NDC 70010-106-44
11-digit product format 700100106
Labeler code 70010
Product ID 70010-106_5d4ec411-0337-37ac-e063-6294a90a6b81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycopyrrolate
Dosage form SOLUTION
Route ORAL
Labeler Granules Pharmaceuticals Inc.
Application ANDA214735
Marketing category ANDA
Marketing start 2025-08-19
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 A214735-001 GLYCOPYRROLATE GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214735-001 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 2026-11-14 07:37:17 2026-10 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214735-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-08-19 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 2027-12-31 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 70010-106-44 Glycopyrrolate Oral Solution 473 mL in 1 BOTTLE SOLUTION 473 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70010-106-44 70010010644 473 mL in 1 BOTTLE (70010-106-44) 473 ml 2025-08-19 No No Current