FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
63323-578
11-digit product format
633230578
Labeler code
63323
Product ID
63323-578_779dc924-ecc3-41cc-8cf9-a7354db4f763
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA209328
Marketing category
ANDA
Marketing start
2017-10-27
Substance
GLYCOPYRROLATE
Active strength
.2 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic 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
63323-578-01Glycopyrrolate25 in 1 CARTONINJECTION, SOLUTION254
63323-578-02Glycopyrrolate25 in 1 CARTONINJECTION, SOLUTION254
63323-578-03Glycopyrrolate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION14
63323-578-04Glycopyrrolate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION24
63323-578-05Glycopyrrolate25 in 1 CARTONINJECTION, SOLUTION254
63323-578-07Glycopyrrolate5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION54
63323-578-18Glycopyrrolate20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION204
63323-578-20Glycopyrrolate10 in 1 CARTONINJECTION, SOLUTION104
63323-578-11Glycopyrrolate25 in 1 CARTONINJECTION, SOLUTION253
63323-578-12Glycopyrrolate25 in 1 CARTONINJECTION, SOLUTION253
63323-578-41Glycopyrrolate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION13
63323-578-42Glycopyrrolate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-578-01ML - Milliliter63323-578b7f46d2f-ea2f-4330-96a8-56c6ef7c4b2212018-07-03
63323-578-02ML - Milliliter63323-5787d9a2c08-fb62-4dcd-b18b-63a5640061e612018-07-03
63323-578-03ML - Milliliter63323-5785929dd36-ff2b-4f07-9c09-8be41789098012018-07-03
63323-578-04ML - Milliliter63323-5782c6613c3-f80c-4f14-b899-e82c58f75d3712018-07-03
63323-578-05ML - Milliliter63323-578949ab91e-7e51-4d31-b454-0293f4b6160512018-07-03
63323-578-07ML - Milliliter63323-578de4b034d-1017-46cb-bd27-b4d33cc3b39112018-07-03
63323-578-11ML - Milliliter63323-5782e2cba68-a76c-48fe-99bd-30eba7b3818c12018-08-13
63323-578-12ML - Milliliter63323-57881049050-8f1a-4f04-8bdb-28a99f620c3c12018-08-13
63323-578-18ML - Milliliter63323-57837b81f3c-b5ec-4597-a0b1-7866cf8e775712018-07-03
63323-578-20ML - Milliliter63323-5780ba83fa3-b05c-4dfa-bc69-2b90b55ad50712018-07-03
63323-578-41ML - Milliliter63323-57801554d58-69a7-4ab1-a7fc-987b83cb23e712018-09-05
63323-578-42ML - Milliliter63323-5786b90b701-7219-4371-bece-0701915749fb12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-578GLYCOPYRROLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 8 package rows20230825_54458620-d888-4df6-ae4b-78c3dfed3423.zip
63323-578GLYCOPYRROLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 4 package rows20241019_ccafb5c2-86dd-4bb2-883a-c13e3171227c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN54458620-d888-4df6-ae4b-78c3dfed34234
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSN54458620-d888-4df6-ae4b-78c3dfed34234
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSN54458620-d888-4df6-ae4b-78c3dfed34234
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD54458620-d888-4df6-ae4b-78c3dfed34234
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCD54458620-d888-4df6-ae4b-78c3dfed34234
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCD54458620-d888-4df6-ae4b-78c3dfed34234
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY54458620-d888-4df6-ae4b-78c3dfed34234
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSY54458620-d888-4df6-ae4b-78c3dfed34234
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSNccafb5c2-86dd-4bb2-883a-c13e3171227c3
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSNccafb5c2-86dd-4bb2-883a-c13e3171227c3
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSNccafb5c2-86dd-4bb2-883a-c13e3171227c3
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCDccafb5c2-86dd-4bb2-883a-c13e3171227c3
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCDccafb5c2-86dd-4bb2-883a-c13e3171227c3
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCDccafb5c2-86dd-4bb2-883a-c13e3171227c3
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSYccafb5c2-86dd-4bb2-883a-c13e3171227c3
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSYccafb5c2-86dd-4bb2-883a-c13e3171227c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-578-016332305780125 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-03) 2017-10-270000-00-00NoNoCurrent
63323-578-026332305780225 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-578-04) 2017-10-270000-00-00NoNoCurrent
63323-578-03633230578031 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-578-04633230578042 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
63323-578-056332305780525 VIAL, MULTI-DOSE in 1 CARTON (63323-578-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-578-07) 2017-10-270000-00-00NoNoCurrent
63323-578-07633230578075 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
63323-578-116332305781125 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-11) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-41) 2017-10-270000-00-00NoNoCurrent
63323-578-126332305781225 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-12) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-578-42) 2017-10-270000-00-00NoNoCurrent
63323-578-186332305781820 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
63323-578-206332305782010 VIAL, MULTI-DOSE in 1 CARTON (63323-578-20) > 20 mL in 1 VIAL, MULTI-DOSE (63323-578-18) 2017-10-270000-00-00NoNoCurrent
63323-578-41633230578411 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-578-42633230578422 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical