Home NDC 71288-415 Glycopyrrolate
Product NDC 71288-415
11-digit product format 712880415
Labeler code 71288
Product ID 71288-415_b3bf6c1b-89c3-44ad-b505-9f2384e15a9b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycopyrrolate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA212802
Marketing category ANDA
Marketing start 2021-07-06
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 42 .
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 A212802-001 GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212802-001 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 2026-08-18 06:07:40 2026-07 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212802-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-07-06 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Glycopyrrolate
Listing expiration 2027-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238212 Internal RxNorm lookup 1731582 Internal RxNorm lookup 1731590 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 71288-415-05 Glycopyrrolate 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 6 71288-415-06 Glycopyrrolate 25 in 1 CARTON INJECTION 25 6 71288-415-20 Glycopyrrolate 20 mL in 1 VIAL, MULTI-DOSE INJECTION 20 6 71288-415-21 Glycopyrrolate 10 in 1 CARTON INJECTION 10 6 71288-415-95 Glycopyrrolate 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 1 71288-415-96 Glycopyrrolate 25 in 1 CARTON INJECTION 25 1 71288-415-97 Glycopyrrolate 20 mL in 1 VIAL, MULTI-DOSE INJECTION 20 1 71288-415-98 Glycopyrrolate 10 in 1 CARTON INJECTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-415 GLYCOPYRROLATE INJECTION [MEITHEAL PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 4 package rows 20231116_02541cfd-b209-49b9-a73f-13ef18dce06d.zip 71288-415 GLYCOPYRROLATE INJECTION [MEITHEAL PHARMACEUTICALS INC.] 1 Current NDC, Legacy NDC, 4 package rows 20230119_02f914a8-2356-4525-91ff-cf0c9e41ba23.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 · 2 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 71288-415-05 71288041505 5 mL in 1 VIAL, MULTI-DOSE 5 ml Historical 71288-415-06 71288041506 25 VIAL, MULTI-DOSE in 1 CARTON (71288-415-06) / 5 mL in 1 VIAL, MULTI-DOSE (71288-415-05) 2021-07-06 0000-00-00 No No Current 71288-415-20 71288041520 20 mL in 1 VIAL, MULTI-DOSE 20 ml Historical 71288-415-21 71288041521 10 VIAL, MULTI-DOSE in 1 CARTON (71288-415-21) / 20 mL in 1 VIAL, MULTI-DOSE (71288-415-20) 2021-07-06 0000-00-00 No No Current 71288-415-95 71288041595 5 mL in 1 VIAL, MULTI-DOSE 5 ml Historical 71288-415-96 71288041596 25 VIAL, MULTI-DOSE in 1 CARTON (71288-415-96) / 5 mL in 1 VIAL, MULTI-DOSE (71288-415-95) 2021-07-06 No No Current 71288-415-97 71288041597 20 mL in 1 VIAL, MULTI-DOSE 20 ml Historical 71288-415-98 71288041598 10 VIAL, MULTI-DOSE in 1 CARTON (71288-415-98) / 20 mL in 1 VIAL, MULTI-DOSE (71288-415-97) 2021-07-06 No No Current