glycopyrrolate

Product NDC
70121-1699
11-digit product format
701211699
Labeler code
70121
Product ID
70121-1699_d5bd5927-af4d-4d76-ac95-1b6f54eefb3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glycopyrrolate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA215333
Marketing category
ANDA
Marketing start
2022-10-25
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
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
GLYCOPYRROLATE.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV92SO9WP2I
Rxcui2101490, 2101495

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
70121-1699-1glycopyrrolate2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION247
70121-1699-7glycopyrrolate10 in 1 CARTONINJECTION, SOLUTION1047

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1699-1ML - Milliliter70121-1699f8e8cd02-e7a2-445b-a81c-78e5ae52fd8512023-07-06
70121-1699-7ML - Milliliter70121-169982d27987-a5a4-4296-9607-1fce177dae1912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1699GLYCOPYRROLATE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC]44Current NDC, Legacy NDC, 2 package rows20250202_741355f5-b695-41bb-a065-4abc687312b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2101490glycopyrrolate 0.2 MG in 1 ML Prefilled SyringePSN741355f5-b695-41bb-a065-4abc687312b247
2101495glycopyrrolate 0.4 MG in 2 ML Prefilled SyringePSN741355f5-b695-41bb-a065-4abc687312b247
21014901 ML glycopyrrolate 0.2 MG/ML Prefilled SyringeSCD741355f5-b695-41bb-a065-4abc687312b247
21014952 ML glycopyrrolate 0.2 MG/ML Prefilled SyringeSCD741355f5-b695-41bb-a065-4abc687312b247
2101490glycopyrrolate 0.2 MG per 1 ML Prefilled SyringeSY741355f5-b695-41bb-a065-4abc687312b247
2101490glycopyrrolate 0.2 MG/ML per 1 ML Prefilled SyringeSY741355f5-b695-41bb-a065-4abc687312b247
2101495glycopyrrolate 0.2 MG/ML per 2 ML Prefilled SyringeSY741355f5-b695-41bb-a065-4abc687312b247
2101495glycopyrrolate 0.4 MG per 2 ML Prefilled SyringeSY741355f5-b695-41bb-a065-4abc687312b247

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1699-1701211699012 mL in 1 SYRINGE, GLASS2 mlHistorical
70121-1699-27012116990212 SYRINGE, GLASS in 1 CARTON (70121-1699-2) > 2 mL in 1 SYRINGE, GLASS (70121-1699-1) 2022-10-250000-00-00NoNoCurrent
70121-1699-77012116990710 SYRINGE, GLASS in 1 CARTON (70121-1699-7) / 2 mL in 1 SYRINGE, GLASS (70121-1699-1) 2022-10-25NoNoHistorical