GLYRX-PF

Product NDC
51754-6000
11-digit product format
517546000
Labeler code
51754
Product ID
51754-6000_442634f7-9858-421d-91db-5bfdb21dcf13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glycopyrrolate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Exela Pharma Sciences, LLC
Application
NDA210997
Marketing category
NDA
Marketing start
2018-08-01
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 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210997-001GLYRX-PFGLYCOPYRROLATE0.2MG/ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD2018-07-11
N210997-002GLYRX-PFGLYCOPYRROLATE0.4MG/2ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-11
N210997-003GLYRX-PFGLYCOPYRROLATE1MG/5ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2020-04-09
N210997-004GLYRX-PFGLYCOPYRROLATE0.6MG/3ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD2020-12-14

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 4 · 154 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210997-001GLYRX-PF0.2MG/ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD2018-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210997-002GLYRX-PF0.4MG/2ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210997-003GLYRX-PF1MG/5ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2020-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210997-004GLYRX-PF0.6MG/3ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD2020-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210997-001GLYRX-PF0.2MG/ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210997-002GLYRX-PF0.4MG/2ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210997-003GLYRX-PF1MG/5ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2020-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210997-004GLYRX-PF0.6MG/3ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD2020-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N210997-001GLYRX-PF0.2MG/ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210997-002GLYRX-PF0.4MG/2ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210997-003GLYRX-PF1MG/5ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2020-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210997-004GLYRX-PF0.6MG/3ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD2020-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210997-001GLYRX-PF0.2MG/ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210997-002GLYRX-PF0.4MG/2ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210997-003GLYRX-PF1MG/5ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2020-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210997-004GLYRX-PF0.6MG/3ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD2020-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210997-001GLYRX-PF0.2MG/ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210997-002GLYRX-PF0.4MG/2ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210997-003GLYRX-PF1MG/5ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2020-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210997-004GLYRX-PF0.6MG/3ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD2020-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210997-001GLYRX-PF0.2MG/ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210997-002GLYRX-PF0.4MG/2ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210997-003GLYRX-PF1MG/5ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2020-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210997-004GLYRX-PF0.6MG/3ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD2020-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210997-001GLYRX-PF0.2MG/ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210997-002GLYRX-PF0.4MG/2ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210997-003GLYRX-PF1MG/5ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2020-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210997-004GLYRX-PF0.6MG/3ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD2020-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210997-001GLYRX-PF0.2MG/ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210997-002GLYRX-PF0.4MG/2ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210997-003GLYRX-PF1MG/5ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2020-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210997-004GLYRX-PF0.6MG/3ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2020-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210997-001GLYRX-PF0.2MG/ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210997-002GLYRX-PF0.4MG/2ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210997-003GLYRX-PF1MG/5ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2020-04-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210997-004GLYRX-PF0.6MG/3ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD2020-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210997-001GLYRX-PF0.2MG/ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N210997-002GLYRX-PF0.4MG/2ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2018-07-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N210997-003GLYRX-PF1MG/5ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2020-04-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N210997-004GLYRX-PF0.6MG/3ML (0.2MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD2020-12-14d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
GLYRX-PF
Listing expiration
2026-12-31

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 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1731582Internal RxNorm lookup
1731590Internal RxNorm lookup
2371710Internal RxNorm lookup
2371715Internal RxNorm lookup
2371718Internal RxNorm lookup
2371796Internal RxNorm lookup
2473383Internal RxNorm lookup
2473384Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2189f3f5-39dc-4e85-b7c6-9515ded59686Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80bProduct name120231002
76dcac30-469f-4f92-9c55-70950d209446Product name120230809
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
132196a6-5117-4b6e-a9dd-27f2793580c6Product name120230112
ac1f888b-a1db-4d2e-abbc-973f21c2ce1bProduct name120220720
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
d84dd569-7bf0-1410-25eb-017ef37dd406Product name920210902
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
58b12de9-b891-41c7-9be6-ff47de5ec28bProduct name120180828
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
9aff7b10-8e47-4b10-9a92-803440a37ce2Product name120180206
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616
fb29b8a9-c2d0-42bb-aea8-9bc2a87db75aProduct name120151113
ab7ba50c-5a47-47e6-8dd6-fa32a52559f6Product name120151109
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
29ae08d1-069f-9822-4820-152d5dc67797Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51754-6000-4GLYRX-PF1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION15
51754-6000-4GLYRX-PF25 in 1 CARTONINJECTION, SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-6000-4ML - Milliliter51754-600081c1fe9e-e766-4a3d-8980-e60226b3605712018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-6000GLYRX-PF (GLYCOPYRROLATE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]4Current NDC, Legacy NDC, 2 package rows20230127_2189f3f5-39dc-4e85-b7c6-9515ded59686.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLYRX-PFGLYCOPYRROLATEExela Pharma Sciences, LLC2189f3f5-39dc-4e85-b7c6-9515ded596862025-07-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 210997
application number: NDA210997
ndc (product): 51754-6000

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN2189f3f5-39dc-4e85-b7c6-9515ded596865
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSN2189f3f5-39dc-4e85-b7c6-9515ded596865
2473383glycopyrrolate 0.6 MG in 3 mL Prefilled SyringePSN2189f3f5-39dc-4e85-b7c6-9515ded596865
2371710glycopyrrolate 1 MG in 5 ML Prefilled SyringePSN2189f3f5-39dc-4e85-b7c6-9515ded596865
2371718Glyrx-PF 0.2 MG in 1 ML InjectionPSN2189f3f5-39dc-4e85-b7c6-9515ded596865
2371796Glyrx-PF 0.4 MG in 2 mL InjectionPSN2189f3f5-39dc-4e85-b7c6-9515ded596865
2473384Glyrx-PF 0.6 MG in 3 mL Prefilled SyringePSN2189f3f5-39dc-4e85-b7c6-9515ded596865
2371715Glyrx-PF 1 MG in 5 ML Prefilled SyringePSN2189f3f5-39dc-4e85-b7c6-9515ded596865
23717181 ML glycopyrrolate 0.2 MG/ML Injection [Glyrx]SBD2189f3f5-39dc-4e85-b7c6-9515ded596865
23717962 ML glycopyrrolate 0.2 MG/ML Injection [Glyrx]SBD2189f3f5-39dc-4e85-b7c6-9515ded596865
24733843 ML glycopyrrolate 0.2 MG/ML Prefilled Syringe [Glyrx]SBD2189f3f5-39dc-4e85-b7c6-9515ded596865
23717155 ML glycopyrrolate 0.2 MG/ML Prefilled Syringe [Glyrx]SBD2189f3f5-39dc-4e85-b7c6-9515ded596865
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD2189f3f5-39dc-4e85-b7c6-9515ded596865
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCD2189f3f5-39dc-4e85-b7c6-9515ded596865
24733833 ML glycopyrrolate 0.2 MG/ML Prefilled SyringeSCD2189f3f5-39dc-4e85-b7c6-9515ded596865
23717105 ML glycopyrrolate 0.2 MG/ML Prefilled SyringeSCD2189f3f5-39dc-4e85-b7c6-9515ded596865
23717181 ML Glyrx 0.2 MG/ML InjectionSY2189f3f5-39dc-4e85-b7c6-9515ded596865
23717962 ML Glyrx 0.2 MG/ML InjectionSY2189f3f5-39dc-4e85-b7c6-9515ded596865
24733843 ML Glyrx 0.2 MG/ML Prefilled SyringeSY2189f3f5-39dc-4e85-b7c6-9515ded596865
23717155 ML Glyrx 0.2 MG/ML Prefilled SyringeSY2189f3f5-39dc-4e85-b7c6-9515ded596865
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY2189f3f5-39dc-4e85-b7c6-9515ded596865
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSY2189f3f5-39dc-4e85-b7c6-9515ded596865
2473383glycopyrrolate 0.6 MG per 3 ML Prefilled SyringeSY2189f3f5-39dc-4e85-b7c6-9515ded596865
2371710glycopyrrolate 1 MG per 5 ML Prefilled SyringeSY2189f3f5-39dc-4e85-b7c6-9515ded596865
2371718Glyrx-PF 0.2 MG per 1 ML InjectionSY2189f3f5-39dc-4e85-b7c6-9515ded596865
2371796Glyrx-PF 0.4 MG per 2 ML InjectionSY2189f3f5-39dc-4e85-b7c6-9515ded596865
2473384Glyrx-PF 0.6 MG per 3 ML Prefilled SyringeSY2189f3f5-39dc-4e85-b7c6-9515ded596865
2371715Glyrx-PF 1 MG per 5 ML Prefilled SyringeSY2189f3f5-39dc-4e85-b7c6-9515ded596865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51754-6000-45175460000425 VIAL, SINGLE-DOSE in 1 CARTON (51754-6000-4) / 1 mL in 1 VIAL, SINGLE-DOSE2018-08-010000-00-00NoNoCurrent