Home NDC 51662-1431 GLYCOPYRROLATE
Product NDC 51662-1431
11-digit product format 516621431
Labeler code 51662
Product ID 51662-1431_2b382c02-1322-a447-e063-6394a90ac5c1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GLYCOPYRROLATE
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA208973
Marketing category ANDA
Marketing start 2019-12-21
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 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 A208973-001 GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208973-001 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.
Product history page 1 of 2 · 41 observed 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 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208973-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2017-06-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238212 Internal RxNorm lookup 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 51662-1431-1 GLYCOPYRROLATE 5 mL in 1 VIAL INJECTION 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1431 GLYCOPYRROLATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 3 Current NDC, Legacy NDC, 1 package rows 20250110_9a3a142c-daaf-79af-e053-2995a90a1c51.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51662-1431-1 51662143101 5 mL in 1 VIAL (51662-1431-1) 5 ml 2019-12-21 0000-00-00 No No Current