Home NDC 0404-9775 Glycopyrrolate
Product NDC 0404-9775
11-digit product format 004049775
Labeler code 0404
Product ID 0404-9775_6b90d651-b13c-441c-ab12-8f866f0bfcbb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glycopyrrolate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA210083
Marketing category ANDA
Marketing start 2025-10-16
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210083-001 GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210083-001 AP
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 2026-02-19 14:30 UTC 2026-02 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210083-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2020-02-21 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Glycopyrrolate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCOPYRROLATE .2 mg/mL
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 1731582 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 0404-9775-01 Glycopyrrolate 1 mL in 1 VIAL INJECTION, SOLUTION 1 1 0404-9775-01 Glycopyrrolate 1 in 1 BAG INJECTION, SOLUTION 1 1
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 · 2 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 0404-9775-01 00404977501 1 VIAL in 1 BAG (0404-9775-01) / 1 mL in 1 VIAL 1 vial 2025-10-16 No No Current