FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
71288-407
Requested package NDC
71288-407-03
11-digit product format
712880407
Labeler code
71288
Product ID
71288-407_69319d90-2a3e-4514-9959-b75779280e89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA211705
Marketing category
ANDA
Marketing start
2019-05-15
Marketing end
0000-00-00
Substance
GLYCOPYRROLATE
Active strength
0 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71288-40771288-407-03DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A211705-001GLYCOPYRROLATEGLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211705-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A211705-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-03-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211705-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATECaplin Steriles Limited765490fa-8378-40c8-9fa7-b0bfa2e1a0a92025-01-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211705
application number: ANDA211705
glycopyrrolateGLYCOPYRROLATEBE Pharmaceuticals Inc.d9df3900-a8c2-438b-8971-ba11ff91f90b2022-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211705
application number: ANDA211705
GlycopyrrolateGLYCOPYRROLATESomerset Therapeutics, LLCa46c5ec1-a1b4-46fc-9b37-8da7f0c983d62022-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211705
application number: ANDA211705

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-407-01ML - Milliliter71288-4074c47a772-d779-4d47-9d19-f726deb5fdbe12019-07-02
71288-407-02ML - Milliliter71288-407edda245a-7edf-4440-b044-4ba8a025597c12019-07-02
71288-407-03ML - Milliliter71288-407b7c17347-971c-4828-a67b-167383a2395512019-07-02
71288-407-04ML - Milliliter71288-4072784112e-0136-4112-a2e9-1c104c314f9512019-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-407-037128804070325 VIAL, SINGLE-DOSE in 1 CARTON (71288-407-03) > 1 mL in 1 VIAL, SINGLE-DOSE (71288-407-01) 2019-05-152023-11-30NoNoCurrent