GLYCOPYRROLATE

Product NDC
51662-1554
11-digit product format
516621554
Labeler code
51662
Product ID
51662-1554_10358054-163e-7a70-e063-6394a90a4b8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYCOPYRROLATE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA090963
Marketing category
ANDA
Marketing start
2021-06-14
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
Rxcui1731590

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
51662-1554-2GLYCOPYRROLATE2 mL in 1 VIALINJECTION22
51662-1554-2GLYCOPYRROLATE1 in 1 POUCHINJECTION12
51662-1554-3GLYCOPYRROLATE25 in 1 CASEINJECTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1554GLYCOPYRROLATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 3 package rows20240201_c4c3be3a-ea28-864f-e053-2a95a90a701a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSNc4c3be3a-ea28-864f-e053-2a95a90a701a2
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCDc4c3be3a-ea28-864f-e053-2a95a90a701a2
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSYc4c3be3a-ea28-864f-e053-2a95a90a701a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1554-2516621554022 mL in 1 VIAL2 mlHistorical
51662-1554-35166215540325 POUCH in 1 CASE (51662-1554-3) / 1 VIAL in 1 POUCH (51662-1554-2) / 2 mL in 1 VIAL25 pouch2021-06-140000-00-00NoNoCurrent