Glycopyrrolate

Product NDC
49884-065
11-digit product format
498840065
Labeler code
49884
Product ID
49884-065_1b923cd6-6a35-4f2f-bcb8-cab438977a08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glycopyrrolate
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA040653
Marketing category
ANDA
Marketing start
2006-09-26
Substance
GLYCOPYRROLATE
Active strength
1 mg/1
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040653-001GLYCOPYRROLATEGLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31
A040653-002GLYCOPYRROLATEGLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040653-001AA
A040653-002AA

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040653-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040653-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040653-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040653-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040653-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040653-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040653-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040653-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040653-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040653-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040653-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040653-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040653-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040653-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040653-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040653-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040653-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040653-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040653-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040653-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040653-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040653-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040653-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040653-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040653-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040653-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040653-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040653-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040653-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040653-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040653-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040653-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040653-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040653-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040653-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040653-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040653-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040653-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040653-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040653-002AA1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCOPYRROLATE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f266d77-4f9e-44c9-a000-2f8fea3ac80bAvailable 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
49884-065-01Glycopyrrolate100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-065-01EA - Each49884-065a626ccd5-11c6-4530-bf33-b9e8bafbd71512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE TABLET [BRYANT RANCH PREPACK]1001
GLYCOPYRRONIUMACTIVE MOIETYA14FB57V1DGLYCOPYRROLATE TABLET [BRYANT RANCH PREPACK]1001
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPGLYCOPYRROLATE TABLET [BRYANT RANCH PREPACK]1001
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GGLYCOPYRROLATE TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYCOPYRROLATE TABLET [BRYANT RANCH PREPACK]1001
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLYCOPYRROLATE TABLET [BRYANT RANCH PREPACK]1001
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYCOPYRROLATE TABLET [BRYANT RANCH PREPACK]1001
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3
GLYCOPYRROLATEACTIVE MOIETYV92SO9WP2IGLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPGLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GGLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-065GLYCOPYRROLATE TABLET [ENDO USA, INC.]6Current NDC, Legacy NDC, 1 package rows20240926_1f266d77-4f9e-44c9-a000-2f8fea3ac80b.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEPar Health USA, LLC1f266d77-4f9e-44c9-a000-2f8fea3ac80b2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653
ndc (product): 49884-065
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackd93a9b2b-708d-4db5-8aae-45fd3a7ca65c2025-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackf7187ddb-ea11-4aa8-8215-a5fcf0f1ca7c2024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack987ba524-361e-49c3-9e00-550a787485422024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack48a8356e-377e-45ef-a1bf-e9ffec0517492024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackfcb295e4-038f-4d4f-8786-4fbcd1d3c2982024-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack33bbc475-2fe3-48ab-8a9d-56d13053593e2024-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197738glycopyrrolate 1 MG Oral TabletPSNf7187ddb-ea11-4aa8-8215-a5fcf0f1ca7c106
197738glycopyrrolate 1 MG Oral TabletSCDf7187ddb-ea11-4aa8-8215-a5fcf0f1ca7c106
197738glycopyrrolate 1 MG Oral TabletPSN48a8356e-377e-45ef-a1bf-e9ffec051749103
197738glycopyrrolate 1 MG Oral TabletSCD48a8356e-377e-45ef-a1bf-e9ffec051749103
197738glycopyrrolate 1 MG Oral TabletPSNd93a9b2b-708d-4db5-8aae-45fd3a7ca65c102
197738glycopyrrolate 1 MG Oral TabletSCDd93a9b2b-708d-4db5-8aae-45fd3a7ca65c102
197738glycopyrrolate 1 MG Oral TabletPSN1f266d77-4f9e-44c9-a000-2f8fea3ac80b6
197739glycopyrrolate 2 MG Oral TabletPSN1f266d77-4f9e-44c9-a000-2f8fea3ac80b6
197738glycopyrrolate 1 MG Oral TabletSCD1f266d77-4f9e-44c9-a000-2f8fea3ac80b6
197739glycopyrrolate 2 MG Oral TabletSCD1f266d77-4f9e-44c9-a000-2f8fea3ac80b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-065-0149884006501100 TABLET in 1 BOTTLE (49884-065-01) 100 tablet2006-09-260000-00-00NoNoCurrent