FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
49884-042
11-digit product format
498840042
Labeler code
49884
Product ID
49884-042_3492c9f9-7d9b-4943-a68c-5e269f056640
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
SOLUTION
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA204438
Marketing category
ANDA
Marketing start
2022-01-04
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glycopyrrolate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCOPYRROLATE1 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV92SO9WP2I
Rxcui999961

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-042-33Glycopyrrolate16 mL in 1 BOTTLESOLUTION1615

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-042-33ML - Milliliter49884-0426549cc29-bf7f-446f-9d66-55cea2bea88d12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-042GLYCOPYRROLATE SOLUTION [ENDO USA, INC.]12Current NDC, Legacy NDC, 1 package rows20240913_ff65c5d3-7ba9-4315-a884-199151eb45a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999961glycopyrrolate 1 MG in 5 mL Oral SolutionPSN579d2499-6520-41fb-ae52-f3d8b9af8950101
999961glycopyrrolate 0.2 MG/ML Oral SolutionSCD579d2499-6520-41fb-ae52-f3d8b9af8950101
999961glycopyrrolate 1 MG per 5 ML Oral SolutionSY579d2499-6520-41fb-ae52-f3d8b9af8950101
999961glycopyrrolate 1 MG in 5 mL Oral SolutionPSNff65c5d3-7ba9-4315-a884-199151eb45a515
999961glycopyrrolate 0.2 MG/ML Oral SolutionSCDff65c5d3-7ba9-4315-a884-199151eb45a515
999961glycopyrrolate 1 MG per 5 ML Oral SolutionSYff65c5d3-7ba9-4315-a884-199151eb45a515
999961glycopyrrolate 1 MG in 5 mL Oral SolutionPSNe58f860b-e955-4d71-a128-93bd3812b08d3
999961glycopyrrolate 0.2 MG/ML Oral SolutionSCDe58f860b-e955-4d71-a128-93bd3812b08d3
999961glycopyrrolate 1 MG per 5 ML Oral SolutionSYe58f860b-e955-4d71-a128-93bd3812b08d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-042-334988400423316 mL in 1 BOTTLE (49884-042-33) 16 ml2022-01-040000-00-00NoNoCurrent