FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
25021-789
11-digit product format
250210789
Labeler code
25021
Product ID
25021-789_782eeda2-3645-44e6-874b-66372687bc12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA212871
Marketing category
ANDA
Marketing start
2022-02-15
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
2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct25021-789DDiscontinued by firm2026-07-31
excluded packagepackage25021-78925021-789-01DDiscontinued by firm2026-07-31
excluded packagepackage25021-78925021-789-02DDiscontinued by firm2026-07-31
excluded packagepackage25021-78925021-789-05DDiscontinued 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
A212871-001GLYCOPYRROLATEGLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2022-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212871-001AP

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 22:54:322026-06A212871-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2022-11-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212871-001AP1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25021-789-012023-03-13C16284748780-1f386c649-b2da-0266-e053-dadaa90a7c1aGlycopyrrolate Injection, USP
25021-789-022023-03-13C16284748780-1f386c649-b2da-0266-e053-dadaa90a7c1aGlycopyrrolate Injection, USP
25021-789-052023-03-13C16284748780-1f386c649-b2da-0266-e053-dadaa90a7c1aGlycopyrrolate Injection, USP
25021-789-012023-01-30C16284748780-1f386c649-b2da-0266-e053-dadaa90a7c1aGlycopyrrolate Injection, USP
25021-789-022023-01-30C16284748780-1f386c649-b2da-0266-e053-dadaa90a7c1aGlycopyrrolate Injection, USP
25021-789-052023-01-30C16284748780-1f386c649-b2da-0266-e053-dadaa90a7c1aGlycopyrrolate Injection, USP

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-789-012502107890110 VIAL in 1 CARTON (25021-789-01) > 1 mL in 1 VIAL10 vial2021-02-150000-00-00NoNoCurrent
25021-789-022502107890210 VIAL in 1 CARTON (25021-789-02) > 2 mL in 1 VIAL10 vial2021-02-150000-00-00NoNoCurrent
25021-789-052502107890510 VIAL in 1 CARTON (25021-789-05) > 5 mL in 1 VIAL10 vial2021-02-150000-00-00NoNoCurrent