Home NDC 76045-203 Glycopyrrolate
Product NDC 76045-203
11-digit product format 760450203
Labeler code 76045
Product ID 76045-203_d8f5e3e4-34e3-4e52-b76d-69e210e649d5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycopyrrolate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA209024
Marketing category ANDA
Marketing start 2018-07-25
Substance GLYCOPYRROLATE
Active strength .2 mg/mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic 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 A209024-001 GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209024-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209024-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2018-10-31 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 .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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2101490 Internal RxNorm lookup 2101495 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 76045-203-01 Glycopyrrolate 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 8 76045-203-01 Glycopyrrolate 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 8 76045-203-02 Glycopyrrolate 2 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 2 8 76045-203-02 Glycopyrrolate 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 8 76045-203-10 Glycopyrrolate 24 in 1 CARTON INJECTION, SOLUTION 24 8 76045-203-20 Glycopyrrolate 24 in 1 CARTON INJECTION, SOLUTION 24 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76045-203 GLYCOPYRROLATE (GLYCOPYRROLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 8 Current NDC, Legacy NDC, 6 package rows 20230825_88d3e865-8dca-4c89-b6f7-a34c481f75b9.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 Marketing end Sample Exclude flag Status 76045-203-01 76045020301 1 mL in 1 SYRINGE, GLASS 1 ml Historical 76045-203-02 76045020302 2 mL in 1 SYRINGE, GLASS 2 ml Historical 76045-203-10 76045020310 24 BLISTER PACK in 1 CARTON (76045-203-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-01) / 1 mL in 1 SYRINGE, GLASS 24 blister pack 2018-07-25 0000-00-00 No No Current 76045-203-20 76045020320 24 BLISTER PACK in 1 CARTON (76045-203-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-02) / 2 mL in 1 SYRINGE, GLASS 24 blister pack 2018-07-25 0000-00-00 No No Current