FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
16729-474
11-digit product format
167290474
Labeler code
16729
Product ID
16729-474_415de5a5-d773-4816-e063-6294a90a6853
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Accord Healthcare, Inc.,
Application
ANDA213238
Marketing category
ANDA
Marketing start
2020-12-10
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-474-03Glycopyrrolate20 mL in 1 VIAL, MULTI-DOSEINJECTION207
16729-474-03Glycopyrrolate10 in 1 CARTONINJECTION107
16729-474-05Glycopyrrolate20 mL in 1 VIAL, MULTI-DOSEINJECTION207
16729-474-05Glycopyrrolate1 in 1 CARTONINJECTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-474-03ML - Milliliter16729-474aa312a66-4f72-42f4-9f56-17ba4a0591c712021-01-08
16729-474-05ML - Milliliter16729-47452eadbc1-78d5-43da-a0de-70dcd14d778d12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-474GLYCOPYRROLATE INJECTION [ACCORD HEALTHCARE, INC.,]6Current NDC, Legacy NDC, 4 package rows20241108_871797f0-697a-4a29-a37b-d06219e8f266.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN871797f0-697a-4a29-a37b-d06219e8f2667
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSN871797f0-697a-4a29-a37b-d06219e8f2667
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSN871797f0-697a-4a29-a37b-d06219e8f2667
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD871797f0-697a-4a29-a37b-d06219e8f2667
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCD871797f0-697a-4a29-a37b-d06219e8f2667
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCD871797f0-697a-4a29-a37b-d06219e8f2667
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY871797f0-697a-4a29-a37b-d06219e8f2667
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSY871797f0-697a-4a29-a37b-d06219e8f2667

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-474-031672904740310 VIAL, MULTI-DOSE in 1 CARTON (16729-474-03) / 20 mL in 1 VIAL, MULTI-DOSE2020-12-100000-00-00NoNoCurrent
16729-474-05167290474051 VIAL, MULTI-DOSE in 1 CARTON (16729-474-05) > 20 mL in 1 VIAL, MULTI-DOSE2020-12-100000-00-00NoNoCurrent