Home NDC 79739-7097-1 Glycopyrrolate
Product NDC 79739-7097
Requested package NDC 79739-7097-1
11-digit product format 797397097
Labeler code 79739
Product ID 79739-7097_9004cf80-5ded-482e-89ca-841fcd89f778
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycopyrrolate
Dosage form TABLET
Route ORAL
Labeler LGM PHARMA SOLUTIONS, LLC
Application ANDA091522
Marketing category ANDA
Marketing start 2012-03-12
Substance GLYCOPYRROLATE
Active strength 1.5 mg/1
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 1 .
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 A091522-001 GLYCOPYRROLATE GLYCOPYRROLATE 1.5MG TABLET / ORAL RS 2012-03-12
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 2 · 41 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 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL RS 2012-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL RS 2012-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL RS 2012-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL RS 2012-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL RS 2012-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL RS 2012-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL RS 2012-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL RS 2012-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL RS 2012-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL RS 2012-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL RS 2012-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL 2012-03-12 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Glycopyrrolate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCOPYRROLATE 1.5 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1247658 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 79739-7097-1 Glycopyrrolate 100 in 1 BOTTLE, PLASTIC TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79739-7097 GLYCOPYRROLATE TABLET [LGM PHARMA SOLUTIONS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20230426_392a969d-1e14-4ad8-835c-a47be4983067.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 79739-7097-1 79739709701 100 TABLET in 1 BOTTLE, PLASTIC (79739-7097-1) 100 tablet 2012-03-12 0000-00-00 No No Current