Home NDC 72887-160 GLYCOPYRROLATE
Product NDC 72887-160
11-digit product format 728870160
Labeler code 72887
Product ID 72887-160_5bc26249-4e9b-4870-a696-99779c90dc27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GLYCOPYRROLATE
Dosage form TABLET
Route ORAL
Labeler FH2 Pharma LLC
Application ANDA091522
Marketing category ANDA
Marketing start 2021-11-29
Substance GLYCOPYRROLATE
Active strength 1.5 mg/1
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 42 .
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 · 42 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 2026-08-18 06:07:40 2026-07 A091522-001 GLYCOPYRROLATE 1.5MG TABLET / ORAL RS 2012-03-12 caaa826d4ba7…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…
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 72887-160-03 GLYCOPYRROLATE 30 in 1 BOTTLE TABLET 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72887-160 GLYCOPYRROLATE TABLET [FH2 PHARMA LLC] 3 Current NDC, Legacy NDC, 1 package rows 20240101_18ca98ed-522d-470f-bb22-908bbd7d489a.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 72887-160-03 72887016003 30 TABLET in 1 BOTTLE (72887-160-03) 30 tablet 2021-11-29 0000-00-00 No No Current