FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
66794-203
11-digit product format
667940203
Labeler code
66794
Product ID
66794-203_3f1431b2-9fb7-4739-e063-6394a90a1ddc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Piramal Critical Care Inc
Application
ANDA210842
Marketing category
ANDA
Marketing start
2019-07-11
Substance
GLYCOPYRROLATE
Active strength
.2 mg/mL
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

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
66794-203-02Glycopyrrolate2 mL in 1 VIAL, GLASSINJECTION, SOLUTION29
66794-203-42Glycopyrrolate25 in 1 CARTONINJECTION, SOLUTION259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66794-203-02ML - Milliliter66794-20398df0f20-a453-49b5-ba68-0df95eca2a5a12019-05-02
66794-203-42ML - Milliliter66794-203e5bc6456-0526-4446-94be-4282f1ed97d312019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66794-203GLYCOPYRROLATE INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC]7Current NDC, Legacy NDC, 2 package rows20231222_83d70378-011b-4ce3-e053-2991aa0a22be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN83d70378-011b-4ce3-e053-2991aa0a22be9
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSN83d70378-011b-4ce3-e053-2991aa0a22be9
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSN83d70378-011b-4ce3-e053-2991aa0a22be9
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD83d70378-011b-4ce3-e053-2991aa0a22be9
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCD83d70378-011b-4ce3-e053-2991aa0a22be9
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCD83d70378-011b-4ce3-e053-2991aa0a22be9
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY83d70378-011b-4ce3-e053-2991aa0a22be9
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSY83d70378-011b-4ce3-e053-2991aa0a22be9
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSN4ecb3435-58e5-46cb-b8c2-85b5fd955f832
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCD4ecb3435-58e5-46cb-b8c2-85b5fd955f832
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSY4ecb3435-58e5-46cb-b8c2-85b5fd955f832
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSN3f2b4281-55f3-43e3-e063-6294a90a56ba1
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCD3f2b4281-55f3-43e3-e063-6294a90a56ba1
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSY3f2b4281-55f3-43e3-e063-6294a90a56ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66794-203-02667940203022 mL in 1 VIAL, GLASS2 mlHistorical
66794-203-426679402034225 VIAL, GLASS in 1 CARTON (66794-203-42) / 2 mL in 1 VIAL, GLASS (66794-203-02) 2019-07-110000-00-00NoNoCurrent