FDA.reportPublic FDA data

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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022571-001CUVPOSAGLYCOPYRROLATE1MG/5MLSOLUTION / ORALAARLD, RS2010-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N022571-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022571-001CUVPOSA1MG/5MLSOLUTION / ORALAARLD, RS2010-07-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022571-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CuvposaGLYCOPYRROLATEMerz Pharmaceuticals, LLCd200bd44-9856-4104-a29e-a4cca3db67372024-12-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 022571
application number: NDA022571
ndc (product): 0259-0501

Additional Listing Data#

Finished product
Yes
Brand name base
Cuvposa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCOPYRROLATE1 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V92SO9WP2IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
999961Internal RxNorm lookup
999965Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d200bd44-9856-4104-a29e-a4cca3db6737Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
138c3de2-4b03-4255-92b5-f022482d81bcProduct name420260113
4dc252b1-bb5f-8bb6-4fa8-f3a45efd810eProduct name520250304
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80bProduct name120231002
76dcac30-469f-4f92-9c55-70950d209446Product name120230809
132196a6-5117-4b6e-a9dd-27f2793580c6Product name120230112
ac1f888b-a1db-4d2e-abbc-973f21c2ce1bProduct name120220720
d84dd569-7bf0-1410-25eb-017ef37dd406Product name920210902
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
58b12de9-b891-41c7-9be6-ff47de5ec28bProduct name120180828
9aff7b10-8e47-4b10-9a92-803440a37ce2Product name120180206
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616
fb29b8a9-c2d0-42bb-aea8-9bc2a87db75aProduct name120151113
ab7ba50c-5a47-47e6-8dd6-fa32a52559f6Product name120151109
29ae08d1-069f-9822-4820-152d5dc67797Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0259-0501-162020-06-08C16284748780-19d75b9d0-649f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CUVPOSA ® safely and effectively. See full prescribing information for CUVPOSA. CUVPOSA (glycopyrrolate) oral solution Initial U.S. Approval: 1961
0259-0501-162020-01-31C16284748780-19d75b9d0-649f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CUVPOSA ® safely and effectively. See full prescribing information for CUVPOSA. CUVPOSA (glycopyrrolate) oral solution Initial U.S. Approval: 1961

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0259-0501-16Cuvposa473 mL in 1 BOTTLELIQUID47320
0259-0501-16Cuvposa1 in 1 CARTONLIQUID120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0259-0501-16ML - Milliliter0259-0501c98c76a9-7388-4de9-98e1-a37ad91e23c412013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
glycopyrrolateACTIVE INGREDIENTV92SO9WP2ICUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC]5
GLYCOPYRRONIUMACTIVE MOIETYA14FB57V1DCUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC]5
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPCUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC]5
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC]5
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TCUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC]5
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC]5
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHCUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC]5
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYCUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC]5
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRCUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC]5
SorbitolINACTIVE INGREDIENT506T60A25RCUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC]5
WaterINACTIVE INGREDIENT059QF0KO0RCUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0259-0501CUVPOSA (GLYCOPYRROLATE) LIQUID [MERZ PHARMACEUTICALS, LLC]20Current NDC, Legacy NDC, 2 package rows20241222_d200bd44-9856-4104-a29e-a4cca3db6737.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999965Cuvposa 1 MG in 5 mL Oral SolutionPSNd200bd44-9856-4104-a29e-a4cca3db673720
999961glycopyrrolate 1 MG in 5 mL Oral SolutionPSNd200bd44-9856-4104-a29e-a4cca3db673720
999965glycopyrrolate 0.2 MG/ML Oral Solution [Cuvposa]SBDd200bd44-9856-4104-a29e-a4cca3db673720
999961glycopyrrolate 0.2 MG/ML Oral SolutionSCDd200bd44-9856-4104-a29e-a4cca3db673720
999965Cuvposa 0.2 MG/ML Oral SolutionSYd200bd44-9856-4104-a29e-a4cca3db673720
999965Cuvposa 1 MG per 5 ML Oral SolutionSYd200bd44-9856-4104-a29e-a4cca3db673720
999961glycopyrrolate 1 MG per 5 ML Oral SolutionSYd200bd44-9856-4104-a29e-a4cca3db673720

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0259-0501-16002590501161 BOTTLE in 1 CARTON (0259-0501-16) / 473 mL in 1 BOTTLE1 bottle2013-01-010000-00-00NoNoCurrent