Home NDC 0259-0501 Cuvposa
Product NDC 0259-0501
11-digit product format 002590501
Labeler code 0259
Product ID 0259-0501_811238a3-579a-4f73-92a4-dbbc1f2d9548
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glycopyrrolate
Dosage form LIQUID
Route ORAL
Labeler Merz Pharmaceuticals, LLC
Application NDA022571
Marketing category NDA
Marketing start 2013-01-01
Substance GLYCOPYRROLATE
Active strength 1 mg/5mL
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 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 · 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 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cuvposa
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCOPYRROLATE 1 mg/5mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 999961 Internal RxNorm lookup 999965 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0259-0501-16 Cuvposa 473 mL in 1 BOTTLE LIQUID 473 20 0259-0501-16 Cuvposa 1 in 1 CARTON LIQUID 1 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded glycopyrrolate ACTIVE INGREDIENT V92SO9WP2I CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC] 5 GLYCOPYRRONIUM ACTIVE MOIETY A14FB57V1D CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC] 5 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC] 5 Glycerin INACTIVE INGREDIENT PDC6A3C0OX CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC] 5 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC] 5 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC] 5 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC] 5 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC] 5 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC] 5 Sorbitol INACTIVE INGREDIENT 506T60A25R CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC] 5 Water INACTIVE INGREDIENT 059QF0KO0R CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0259-0501 CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC] 20 Current NDC, Legacy NDC, 2 package rows 20241222_d200bd44-9856-4104-a29e-a4cca3db6737.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.
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 0259-0501-16 00259050116 1 BOTTLE in 1 CARTON (0259-0501-16) / 473 mL in 1 BOTTLE 1 bottle 2013-01-01 0000-00-00 No No Current