FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
71288-414
11-digit product format
712880414
Labeler code
71288
Product ID
71288-414_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
71288-414-01Glycopyrrolate1 mL in 1 VIAL, SINGLE-DOSEINJECTION16
71288-414-02Glycopyrrolate2 mL in 1 VIAL, SINGLE-DOSEINJECTION26
71288-414-03Glycopyrrolate25 in 1 CARTONINJECTION256
71288-414-04Glycopyrrolate25 in 1 CARTONINJECTION256
71288-414-91Glycopyrrolate1 mL in 1 VIAL, SINGLE-DOSEINJECTION11
71288-414-92Glycopyrrolate25 in 1 CARTONINJECTION251
71288-414-93Glycopyrrolate2 mL in 1 VIAL, SINGLE-DOSEINJECTION21
71288-414-94Glycopyrrolate25 in 1 CARTONINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-414-01ML - Milliliter71288-414f5fff38b-36ce-4663-8728-bbc950b0087612022-07-06
71288-414-02ML - Milliliter71288-414840f5850-63b0-474b-a77c-dce5a133d34812022-08-04
71288-414-03ML - Milliliter71288-41483d53e58-185a-4a78-a2c7-8871249904fb12022-07-06
71288-414-04ML - Milliliter71288-4147eeb2da7-edbf-4246-b5ea-dc49ff7f53aa12022-08-04
71288-414-91ML - Milliliter71288-41493b1cfb8-5cae-4638-ab3d-4e8cd036aac612023-08-08
71288-414-92ML - Milliliter71288-4144ee266fd-f377-4f69-94fe-f952d4b2f15d12023-08-08
71288-414-93ML - Milliliter71288-4149bfdc480-17ad-462a-8df4-e412822271ac12023-08-08
71288-414-94ML - Milliliter71288-41491e85e8e-6dc8-4139-9c81-28fc6cadc97912023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-414GLYCOPYRROLATE INJECTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 4 package rows20231116_02541cfd-b209-49b9-a73f-13ef18dce06d.zip
71288-414GLYCOPYRROLATE 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
71288-414-01712880414011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
71288-414-02712880414022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
71288-414-037128804140325 VIAL, SINGLE-DOSE in 1 CARTON (71288-414-03) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-414-01) 2021-07-060000-00-00NoNoCurrent
71288-414-047128804140425 VIAL, SINGLE-DOSE in 1 CARTON (71288-414-04) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-414-02) 2021-07-060000-00-00NoNoCurrent
71288-414-91712880414911 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
71288-414-927128804149225 VIAL, SINGLE-DOSE in 1 CARTON (71288-414-92) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-414-91) 2021-07-06NoNoHistorical
71288-414-93712880414932 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
71288-414-947128804149425 VIAL, SINGLE-DOSE in 1 CARTON (71288-414-94) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-414-93) 2021-07-06NoNoHistorical