Home NDC 70518-4537 GLYCOPYRROLATE
Product NDC 70518-4537
11-digit product format 705184537
Labeler code 70518
Product ID 70518-4537_5b9bdb65-2322-b56c-e063-6394a90a4c28
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GLYCOPYRROLATE
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA212696
Marketing category ANDA
Marketing start 2025-12-17
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 2027-12-31
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 A212696-001 GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 A212696-002 GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10
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.
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 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212696-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2024-07-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212696-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2024-07-10 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCOPYRROLATE 2 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4537-0 GLYCOPYRROLATE 100 in 1 BOX TABLET 100 1 70518-4537-1 GLYCOPYRROLATE 1 in 1 POUCH TABLET 1 1
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 Sample Exclude flag Status 70518-4537-0 70518453700 100 POUCH in 1 BOX (70518-4537-0) / 1 TABLET in 1 POUCH (70518-4537-1) 100 pouch 2025-12-17 No No Current 70518-4537-1 70518453701 1 in 1 POUCH Historical