Home NDC 70700-264 GLYCOPYRROLATE 1ML
Product NDC 70700-264
11-digit product format 707000264
Labeler code 70700
Product ID 70700-264_de0df13f-d2ca-26d3-fcf4-0eb177e4d1b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycopyrrolate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler XIROMED LLC
Application ANDA212227
Marketing category ANDA
Marketing start 2018-08-03
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 A212227-001 GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2021-03-04
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 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2021-03-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2021-03-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2021-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2021-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2021-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2021-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2021-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2021-03-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212227-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2021-03-04 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 1ML
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 70700-264-22 GLYCOPYRROLATE 1ML 1 in 1 CARTON INJECTION 1 3 70700-264-22 GLYCOPYRROLATE 1ML 1 mL in 1 VIAL INJECTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70700-264 GLYCOPYRROLATE 1ML (GLYCOPYRROLATE) INJECTION [XIROMED LLC] 3 Current NDC, 2 package rows 20231024_1bb2fa8a-3318-1e9a-2c79-8371bcae3d1c.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 70700-264-22 70700026422 1 VIAL in 1 CARTON (70700-264-22) / 1 mL in 1 VIAL 1 vial 2023-10-23 No No Current