FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
0143-9682
11-digit product format
001439682
Labeler code
0143
Product ID
0143-9682_8ed339c6-d65f-4b1c-8e23-301f75258c2e
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
2011-09-21
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9682-01Glycopyrrolate1 mL in 1 VIALINJECTION16
0143-9682-25Glycopyrrolate25 in 1 CARTONINJECTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9682-01ML - Milliliter0143-9682b00d3e57-bba5-4ffd-b8c0-e59298a4cdb912013-09-04
0143-9682-25ML - Milliliter0143-96828f2ace03-ca90-4bfc-a8ad-28a026e1598a12013-09-04

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
WATERINACTIVE INGREDIENT059QF0KO0RGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE INJECTION [CARDINAL HEALTH]1
GLYCOPYRRONIUMACTIVE MOIETYA14FB57V1DGLYCOPYRROLATE INJECTION [CARDINAL HEALTH]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHGLYCOPYRROLATE INJECTION [CARDINAL HEALTH]1
WATERINACTIVE INGREDIENT059QF0KO0RGLYCOPYRROLATE INJECTION [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9682GLYCOPYRROLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 2 package rows20220324_516cc4f8-3583-4405-ab66-29d4fcc56d05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN9be0ad4e-3efa-1a24-e053-2995a90a60d58
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD9be0ad4e-3efa-1a24-e053-2995a90a60d58
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY9be0ad4e-3efa-1a24-e053-2995a90a60d58
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN225d95b4-7f8f-44c2-8fc2-93b75d9cc6517
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN65688bed-0d70-4b51-8301-1948b1deade17
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD225d95b4-7f8f-44c2-8fc2-93b75d9cc6517
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD65688bed-0d70-4b51-8301-1948b1deade17
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY65688bed-0d70-4b51-8301-1948b1deade17
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY225d95b4-7f8f-44c2-8fc2-93b75d9cc6517
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN516cc4f8-3583-4405-ab66-29d4fcc56d056
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSN516cc4f8-3583-4405-ab66-29d4fcc56d056
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSN516cc4f8-3583-4405-ab66-29d4fcc56d056
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD516cc4f8-3583-4405-ab66-29d4fcc56d056
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCD516cc4f8-3583-4405-ab66-29d4fcc56d056
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCD516cc4f8-3583-4405-ab66-29d4fcc56d056
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY516cc4f8-3583-4405-ab66-29d4fcc56d056
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSY516cc4f8-3583-4405-ab66-29d4fcc56d056

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9682-01001439682011 mL in 1 VIAL1 mlHistorical
0143-9682-250014396822525 VIAL in 1 CARTON (0143-9682-25) / 1 mL in 1 VIAL (0143-9682-01) 25 vial2011-09-210000-00-00NoNoCurrent