Home NDC 68022-0156 Glycopyrrolate Oral Solution
Product NDC 68022-0156
11-digit product format 680220156
Labeler code 68022
Product ID 68022-0156_e313b490-05a5-7649-e053-2a95a90ab87f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycopyrrolate Oral Solution
Dosage form LIQUID
Route ORAL
Labeler Suven Pharmaceuticals Limited
Application ANDA212467
Marketing category ANDA
Marketing start 2022-07-05
Marketing end 0000-00-00
Substance GLYCOPYRROLATE
Active strength 1 mg/5mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 A212467-001 GLYCOPYRROLATE GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212467-001 AA
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 2026-02-19 14:30 UTC 2026-02 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212467-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68022-0156 GLYCOPYRROLATE ORAL SOLUTION LIQUID [SUVEN PHARMACEUTICALS LIMITED] 5 Legacy NDC 20240118_78ff2314-3a87-8554-e053-2991aa0a33ea.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68022-0156-1 68022015601 1 BOTTLE in 1 CARTON (68022-0156-1) > 500 mL in 1 BOTTLE 1 bottle 2022-07-05 0000-00-00 No No Current