Home NDC 0259-0502 Glycopyrrolate
Product NDC 0259-0502
11-digit product format 002590502
Labeler code 0259
Product ID 0259-0502_2d1b0e12-b007-422b-8375-a9b48a24cea7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycopyrrolate
Dosage form LIQUID
Route ORAL
Labeler Merz Pharmaceuticals, LLC
Application NDA022571
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-01-04
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0259-0502-16 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0259-0502-16 f5e01cc5f278…a2eaf40c39c3…
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 N022571-001 CUVPOSA GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022571-001 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.
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 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 48 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cuvposa GLYCOPYRROLATE Merz Pharmaceuticals, LLC d200bd44-9856-4104-a29e-a4cca3db6737 2024-12-19 Warnings, Adverse reactions Exact identifier application applno (NDA): 022571 application number: NDA022571
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0259-0502-16 00259050216 1 BOTTLE in 1 CARTON (0259-0502-16) > 473 mL in 1 BOTTLE 1 bottle 2022-01-04 0000-00-00 No No Current