Home NDC 71921-110 Glycopyrrolate
Product NDC 71921-110
11-digit product format 719210110
Labeler code 71921
Product ID 71921-110_2cda1ed5-10bb-4651-acbf-be44ad709665
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycopyrrolate
Dosage form TABLET
Route ORAL
Labeler Florida Pharmaceutical Products, LLC
Application ANDA091182
Marketing category ANDA
Marketing start 2026-02-12
Substance GLYCOPYRROLATE
Active strength 1 mg/1
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091182-001 GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 A091182-002 GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091182-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2014-02-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091182-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2014-02-03 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Glycopyrrolate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCOPYRROLATE 1 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197738 Internal RxNorm lookup 197739 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 71921-110-01 Glycopyrrolate 100 in 1 BOTTLE TABLET 100 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71921-110-01 71921011001 100 TABLET in 1 BOTTLE (71921-110-01) 100 tablet 2026-02-12 No No Current