FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
0143-9585
11-digit product format
001439585
Labeler code
0143
Product ID
0143-9585_d0ab666e-f450-4de6-a324-9c45be693df0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA090963
Marketing category
ANDA
Marketing start
2015-06-01
Substance
GLYCOPYRROLATE
Active strength
.2 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCOPYRROLATE.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV92SO9WP2I
Rxcui238212, 1731582, 1731590

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
0143-9585-01Glycopyrrolate5 mL in 1 VIAL, MULTI-DOSEINJECTION510
0143-9585-25Glycopyrrolate25 in 1 CARTONINJECTION2510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9585-01ML - Milliliter0143-9585d693871a-0aad-42e6-bdc4-5b29a303198312015-08-04
0143-9585-25ML - Milliliter0143-9585bbb056c6-0f49-4fbb-a423-3b136c44e22812015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
GLYCOPYRRONIUMACTIVE MOIETYA14FB57V1DGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
WATERINACTIVE INGREDIENT059QF0KO0RGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9585GLYCOPYRROLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20220311_d5a18d74-0d40-46e2-aa0a-41d18609a536.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSNd5a18d74-0d40-46e2-aa0a-41d18609a53610
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSNd5a18d74-0d40-46e2-aa0a-41d18609a53610
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSNd5a18d74-0d40-46e2-aa0a-41d18609a53610
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCDd5a18d74-0d40-46e2-aa0a-41d18609a53610
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCDd5a18d74-0d40-46e2-aa0a-41d18609a53610
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCDd5a18d74-0d40-46e2-aa0a-41d18609a53610
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSYd5a18d74-0d40-46e2-aa0a-41d18609a53610
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSYd5a18d74-0d40-46e2-aa0a-41d18609a53610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9585-01001439585015 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
0143-9585-250014395852525 VIAL, MULTI-DOSE in 1 CARTON (0143-9585-25) / 5 mL in 1 VIAL, MULTI-DOSE (0143-9585-01) 2015-06-010000-00-00NoNoCurrent