FDA.reportPublic FDA data

GLYCOPYRROLATE

Product NDC
43547-543
11-digit product format
435470543
Labeler code
43547
Product ID
43547-543_ce7c9cab-8100-4373-a560-f138745e839d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Solco Healthcare US, LLC
Application
ANDA210927
Marketing category
ANDA
Marketing start
2019-03-20
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
Rxcui1731582, 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
43547-543-01GLYCOPYRROLATE1 mL in 1 VIAL, SINGLE-DOSEINJECTION13
43547-543-25GLYCOPYRROLATE25 in 1 CARTONINJECTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-543-01ML - Milliliter43547-543b51f6563-f226-4392-8aa9-e5612638896c12020-01-03
43547-543-25ML - Milliliter43547-543554e30a2-cd6c-4b97-9ee6-581c18d8751b12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-543GLYCOPYRROLATE INJECTION [SOLCO HEALTHCARE US, LLC]1Current NDC, Legacy NDC, 2 package rows20190320_3707f06a-6cba-4f5c-86ab-fb95bc2a933c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN3707f06a-6cba-4f5c-86ab-fb95bc2a933c3
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSN3707f06a-6cba-4f5c-86ab-fb95bc2a933c3
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD3707f06a-6cba-4f5c-86ab-fb95bc2a933c3
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCD3707f06a-6cba-4f5c-86ab-fb95bc2a933c3
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY3707f06a-6cba-4f5c-86ab-fb95bc2a933c3
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSY3707f06a-6cba-4f5c-86ab-fb95bc2a933c3
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSNa2a2a03f-21cc-5fec-e053-2995a90a84cb2
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCDa2a2a03f-21cc-5fec-e053-2995a90a84cb2
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSYa2a2a03f-21cc-5fec-e053-2995a90a84cb2
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN3edcc39d-0e29-4585-e063-6394a90ad5121
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD3edcc39d-0e29-4585-e063-6394a90ad5121
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY3edcc39d-0e29-4585-e063-6394a90ad5121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-543-01435470543011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
43547-543-254354705432525 VIAL, SINGLE-DOSE in 1 CARTON (43547-543-25) / 1 mL in 1 VIAL, SINGLE-DOSE (43547-543-01) 2019-03-200000-00-00NoNoCurrent