Home NDC 70756-633-10 Glycopyrrolate
Product NDC 70756-633
Requested package NDC 70756-633-10
11-digit product format 707560633
Labeler code 70756
Product ID 70756-633_19408a9d-222f-42e1-b28a-801178b0f5f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycopyrrolate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Lifestar Pharma LLC
Application ANDA217354
Marketing category ANDA
Marketing start 2023-02-28
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 2027-12-31
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 A217354-001 GLYCOPYRROLATE GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27
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 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2023-02-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2023-02-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP 2023-02-27 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217354-001 GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION 2023-02-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217354-001 AP 1 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217354-001 AP 1 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A217354-001 AP 1 053a50430f4f…
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 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 70756-633-10 Glycopyrrolate 10 in 1 CARTON INJECTION 10 6 70756-633-25 Glycopyrrolate 25 in 1 CARTON INJECTION 25 6 70756-633-85 Glycopyrrolate 5 mL in 1 VIAL INJECTION 5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70756-633 GLYCOPYRROLATE INJECTION [LIFESTAR PHARMA LLC] 4 Current NDC, 3 package rows 20230318_0f4a4b94-71e0-49ed-8f1e-c760e4dd3137.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 70756-633-10 70756063310 10 CARTON in 1 CARTON (70756-633-10) / 25 VIAL in 1 CARTON (70756-633-25) / 5 mL in 1 VIAL (70756-633-85) 10 carton 2023-02-28 No No Current