Home NDC 71656-061 glycopyrrolate
Product NDC 71656-061
11-digit product format 716560061
Labeler code 71656
Product ID 71656-061_26be665a-acae-22fd-e063-6394a90a2a0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glycopyrrolate
Dosage form SOLUTION
Route ORAL
Labeler Saptalis Pharmaceuticals, LLC.
Application ANDA216297
Marketing category ANDA
Marketing start 2024-11-25
Substance GLYCOPYRROLATE
Active strength 1 mg/5mL
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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216297-001 GLYCOPYRROLATE GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-10-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216297-001 AA
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A216297-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-10-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216297-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216297-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216297-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216297-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216297-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216297-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216297-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216297-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-10-07 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216297-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216297-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-10-07 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216297-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2024-10-07 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base glycopyrrolate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCOPYRROLATE 1 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V92SO9WP2I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 999961 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71656-061-16 glycopyrrolate 1 in 1 BOTTLE SOLUTION 1 2 71656-061-16 glycopyrrolate 473 mL in 1 BOTTLE SOLUTION 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71656-061 GLYCOPYRROLATE SOLUTION [SAPTALIS PHARMACEUTICALS, LLC.] 2 Current NDC, 2 package rows 20241126_3e6f8091-d6fe-4c8f-b897-606a70bf74bc.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71656-061-16 71656006116 1 BOTTLE in 1 BOTTLE (71656-061-16) / 473 mL in 1 BOTTLE 1 bottle 2024-11-25 No No Current