Home NDC 72162-1478 Glycopyrrolate
Product NDC 72162-1478
11-digit product format 721621478
Labeler code 72162
Product ID 72162-1478_f46bf32b-3022-4191-a54e-f2f8ea108e53
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glycopyrrolate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA040653
Marketing category ANDA
Marketing start 2006-09-26
Substance GLYCOPYRROLATE
Active strength 2 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 44 .
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 A040653-001 GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 A040653-002 GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31
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 · 88 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 2026-10-15 13:18:30 2026-09 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040653-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA RS 2006-08-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040653-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA RS 2006-08-31 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCOPYRROLATE 2 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 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 72162-1478-1 Glycopyrrolate 100 in 1 BOTTLE TABLET 100 101
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-1478 GLYCOPYRROLATE TABLET [BRYANT RANCH PREPACK] 101 Current NDC, 1 package rows 20241017_33bbc475-2fe3-48ab-8a9d-56d13053593e.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 · 5 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 72162-1478-1 72162147801 100 TABLET in 1 BOTTLE (72162-1478-1) 100 tablet 2024-10-04 No No Current