FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
71288-415
11-digit product format
712880415
Labeler code
71288
Product ID
71288-415_b3bf6c1b-89c3-44ad-b505-9f2384e15a9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA212802
Marketing category
ANDA
Marketing start
2021-07-06
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-415-05Glycopyrrolate5 mL in 1 VIAL, MULTI-DOSEINJECTION56
71288-415-06Glycopyrrolate25 in 1 CARTONINJECTION256
71288-415-20Glycopyrrolate20 mL in 1 VIAL, MULTI-DOSEINJECTION206
71288-415-21Glycopyrrolate10 in 1 CARTONINJECTION106
71288-415-95Glycopyrrolate5 mL in 1 VIAL, MULTI-DOSEINJECTION51
71288-415-96Glycopyrrolate25 in 1 CARTONINJECTION251
71288-415-97Glycopyrrolate20 mL in 1 VIAL, MULTI-DOSEINJECTION201
71288-415-98Glycopyrrolate10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-415-05ML - Milliliter71288-415e28daf9c-36b4-48fc-a82d-bf37677148a012022-08-04
71288-415-06ML - Milliliter71288-415c208b466-fe57-4cc8-93f2-d3d871c0823112022-08-04
71288-415-20ML - Milliliter71288-4153194b506-003e-42d2-a906-8baf97c5397f12022-05-04
71288-415-21ML - Milliliter71288-4158edc4df4-995d-47d0-91e2-be09616cf2b212022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-415GLYCOPYRROLATE INJECTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 4 package rows20231116_02541cfd-b209-49b9-a73f-13ef18dce06d.zip
71288-415GLYCOPYRROLATE INJECTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 4 package rows20230119_02f914a8-2356-4525-91ff-cf0c9e41ba23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN02541cfd-b209-49b9-a73f-13ef18dce06d6
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSN02541cfd-b209-49b9-a73f-13ef18dce06d6
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSN02541cfd-b209-49b9-a73f-13ef18dce06d6
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD02541cfd-b209-49b9-a73f-13ef18dce06d6
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCD02541cfd-b209-49b9-a73f-13ef18dce06d6
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCD02541cfd-b209-49b9-a73f-13ef18dce06d6
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY02541cfd-b209-49b9-a73f-13ef18dce06d6
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSY02541cfd-b209-49b9-a73f-13ef18dce06d6
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN02f914a8-2356-4525-91ff-cf0c9e41ba231
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSN02f914a8-2356-4525-91ff-cf0c9e41ba231
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSN02f914a8-2356-4525-91ff-cf0c9e41ba231
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD02f914a8-2356-4525-91ff-cf0c9e41ba231
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCD02f914a8-2356-4525-91ff-cf0c9e41ba231
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCD02f914a8-2356-4525-91ff-cf0c9e41ba231
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY02f914a8-2356-4525-91ff-cf0c9e41ba231
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSY02f914a8-2356-4525-91ff-cf0c9e41ba231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-415-05712880415055 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
71288-415-067128804150625 VIAL, MULTI-DOSE in 1 CARTON (71288-415-06) / 5 mL in 1 VIAL, MULTI-DOSE (71288-415-05) 2021-07-060000-00-00NoNoCurrent
71288-415-207128804152020 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
71288-415-217128804152110 VIAL, MULTI-DOSE in 1 CARTON (71288-415-21) / 20 mL in 1 VIAL, MULTI-DOSE (71288-415-20) 2021-07-060000-00-00NoNoCurrent
71288-415-95712880415955 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
71288-415-967128804159625 VIAL, MULTI-DOSE in 1 CARTON (71288-415-96) / 5 mL in 1 VIAL, MULTI-DOSE (71288-415-95) 2021-07-06NoNoHistorical
71288-415-977128804159720 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
71288-415-987128804159810 VIAL, MULTI-DOSE in 1 CARTON (71288-415-98) / 20 mL in 1 VIAL, MULTI-DOSE (71288-415-97) 2021-07-06NoNoHistorical