Glycopyrrolate

Product NDC
66794-202
11-digit product format
667940202
Labeler code
66794
Product ID
66794-202_3f1431b2-9fb7-4739-e063-6394a90a1ddc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Piramal Critical Care Inc
Application
ANDA210842
Marketing category
ANDA
Marketing start
2019-07-11
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210842-001GLYCOPYRROLATEGLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A210842-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-253f01610625f2…
2019-09-15 20:21 UTC2019-09A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210842-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-25e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210842-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210842-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210842-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210842-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210842-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210842-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210842-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210842-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210842-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210842-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210842-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210842-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210842-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210842-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210842-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210842-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210842-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210842-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210842-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210842-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210842-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210842-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A210842-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210842-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210842-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210842-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A210842-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210842-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210842-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210842-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210842-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210842-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210842-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210842-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210842-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210842-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210842-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210842-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210842-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210842-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Glycopyrrolate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCOPYRROLATE.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V92SO9WP2IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238212Internal RxNorm lookup
1731582Internal RxNorm lookup
1731590Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
83d70378-011b-4ce3-e053-2991aa0a22beAvailable on FDA.report

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
66794-202-02Glycopyrrolate1 mL in 1 VIAL, GLASSINJECTION, SOLUTION19
66794-202-42Glycopyrrolate25 in 1 CARTONINJECTION, SOLUTION259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66794-202-02ML - Milliliter66794-202966acb00-e4fb-4676-a4a4-b517c45e05db12019-05-02
66794-202-42ML - Milliliter66794-2025142a901-4448-49b6-a7f6-c0d9f6b3a58a12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66794-202GLYCOPYRROLATE INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC]7Current NDC, Legacy NDC, 2 package rows20231222_83d70378-011b-4ce3-e053-2991aa0a22be.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEPiramal Critical Care Inc83d70378-011b-4ce3-e053-2991aa0a22be2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210842
application number: ANDA210842
ndc (product): 66794-202
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution430635e8-7c9e-77f6-e063-6294a90a4c8a2025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210842
application number: ANDA210842
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.83602e34-7a8c-4606-b43e-23ab909b6c1a2025-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210842
application number: ANDA210842
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.74d51ba3-0ca0-4a04-aa87-1c243f885bd82025-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210842
application number: ANDA210842
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.4ecb3435-58e5-46cb-b8c2-85b5fd955f832025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210842
application number: ANDA210842
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution3f2b4281-55f3-43e3-e063-6294a90a56ba2025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210842
application number: ANDA210842
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution3edd6a26-dd0f-2411-e063-6394a90affa22025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210842
application number: ANDA210842
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC8f126596-7fbf-7a48-e053-2995a90abac72023-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210842
application number: ANDA210842
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC8f12016d-9033-00b4-e053-2a95a90ad02a2023-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210842
application number: ANDA210842
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC9e5113b7-1c0c-24bd-e053-2995a90ab94b2023-05-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210842
application number: ANDA210842

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN83d70378-011b-4ce3-e053-2991aa0a22be9
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSN83d70378-011b-4ce3-e053-2991aa0a22be9
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSN83d70378-011b-4ce3-e053-2991aa0a22be9
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD83d70378-011b-4ce3-e053-2991aa0a22be9
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCD83d70378-011b-4ce3-e053-2991aa0a22be9
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCD83d70378-011b-4ce3-e053-2991aa0a22be9
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY83d70378-011b-4ce3-e053-2991aa0a22be9
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSY83d70378-011b-4ce3-e053-2991aa0a22be9
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN8f12016d-9033-00b4-e053-2a95a90ad02a2
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD8f12016d-9033-00b4-e053-2a95a90ad02a2
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY8f12016d-9033-00b4-e053-2a95a90ad02a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66794-202-02667940202021 mL in 1 VIAL, GLASS1 mlHistorical
66794-202-426679402024225 VIAL, GLASS in 1 CARTON (66794-202-42) / 1 mL in 1 VIAL, GLASS (66794-202-02) 2019-07-110000-00-00NoNoCurrent