FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
70121-1397
11-digit product format
701211397
Labeler code
70121
Product ID
70121-1397_eef9f866-2de4-4bc2-881d-c0dcb5422d3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA208973
Marketing category
ANDA
Marketing start
2017-06-15
Substance
GLYCOPYRROLATE
Active strength
4 mg/20mL
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
GLYCOPYRROLATE4 mg/20mL

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
70121-1397-1Glycopyrrolate20 mL in 1 VIALINJECTION2010
70121-1397-7Glycopyrrolate10 in 1 CARTONINJECTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1397-1ML - Milliliter70121-13970896de02-42ec-4271-ac03-57381530fd6212017-07-07
70121-1397-7ML - Milliliter70121-13974066d685-f308-4ded-9e5d-adce0fb49fe712017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1397GLYCOPYRROLATE INJECTION [AMNEAL PHARMACEUTICALS LLC]9Current NDC, Legacy NDC, 2 package rows20240730_bbab4cf1-0441-4fc4-9de9-e4117fa19faa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSNbbab4cf1-0441-4fc4-9de9-e4117fa19faa10
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSNbbab4cf1-0441-4fc4-9de9-e4117fa19faa10
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSNbbab4cf1-0441-4fc4-9de9-e4117fa19faa10
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCDbbab4cf1-0441-4fc4-9de9-e4117fa19faa10
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCDbbab4cf1-0441-4fc4-9de9-e4117fa19faa10
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCDbbab4cf1-0441-4fc4-9de9-e4117fa19faa10
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSYbbab4cf1-0441-4fc4-9de9-e4117fa19faa10
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSYbbab4cf1-0441-4fc4-9de9-e4117fa19faa10
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSNe8bb95ed-09f1-fcf1-e053-2a95a90a93e54
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCDe8bb95ed-09f1-fcf1-e053-2a95a90a93e54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1397-17012113970120 mL in 1 VIAL20 mlHistorical
70121-1397-77012113970710 VIAL in 1 CARTON (70121-1397-7) / 20 mL in 1 VIAL (70121-1397-1) 10 vial2017-06-150000-00-00NoNoCurrent