Home NDC 42023-269 PREVDUO
Product NDC 42023-269
11-digit product format 420230269
Labeler code 42023
Product ID 42023-269_a1b07822-805f-4c68-914f-1db1cead480a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name neostigmine methylsulfate and glycopyrrolate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Endo USA
Application NDA216903
Marketing category NDA
Marketing start 2023-05-15
Substance GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE
Active strength .2; 1 mg/mL; mg/mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [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 N216903-001 PREVDUO GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2023-02-23
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216903-001 10456354 2038-10-25 Drug product 2023-02-24 N216903-001 11110054 2038-10-25 Drug product 2023-02-24 N216903-001 11938217 2038-10-25 Drug product 2024-03-28 N216903-001 12151020 2038-10-25 Drug product 2024-11-27 N216903-001 12383491 2038-10-25 Drug product 2025-08-21
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 2026-02-19 14:30 UTC 2026-02 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-23 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216903-001 PREVDUO 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2023-02-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N216903-001 10456354 2038-10-25 Drug product 2023-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216903-001 11110054 2038-10-25 Drug product 2023-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216903-001 11938217 2038-10-25 Drug product 2024-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216903-001 12151020 2038-10-25 Drug product 2024-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216903-001 12383491 2038-10-25 Drug product 2025-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216903-001 10456354 2038-10-25 Drug product 2023-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216903-001 11110054 2038-10-25 Drug product 2023-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216903-001 11938217 2038-10-25 Drug product 2024-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216903-001 12151020 2038-10-25 Drug product 2024-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216903-001 12383491 2038-10-25 Drug product 2025-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216903-001 10456354 2038-10-25 Drug product 2023-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216903-001 11110054 2038-10-25 Drug product 2023-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216903-001 11938217 2038-10-25 Drug product 2024-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216903-001 12151020 2038-10-25 Drug product 2024-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216903-001 10456354 2038-10-25 Drug product 2023-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216903-001 11110054 2038-10-25 Drug product 2023-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216903-001 11938217 2038-10-25 Drug product 2024-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216903-001 12151020 2038-10-25 Drug product 2024-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216903-001 10456354 2038-10-25 Drug product 2023-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216903-001 11110054 2038-10-25 Drug product 2023-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216903-001 11938217 2038-10-25 Drug product 2024-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216903-001 12151020 2038-10-25 Drug product 2024-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216903-001 10456354 2038-10-25 Drug product 2023-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216903-001 11110054 2038-10-25 Drug product 2023-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216903-001 11938217 2038-10-25 Drug product 2024-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216903-001 12151020 2038-10-25 Drug product 2024-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216903-001 10456354 2038-10-25 Drug product 2023-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216903-001 11110054 2038-10-25 Drug product 2023-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216903-001 11938217 2038-10-25 Drug product 2024-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216903-001 12151020 2038-10-25 Drug product 2024-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216903-001 10456354 2038-10-25 Drug product 2023-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216903-001 11110054 2038-10-25 Drug product 2023-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216903-001 11938217 2038-10-25 Drug product 2024-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216903-001 10456354 2038-10-25 Drug product 2023-02-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216903-001 11110054 2038-10-25 Drug product 2023-02-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216903-001 11938217 2038-10-25 Drug product 2024-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216903-001 10456354 2038-10-25 Drug product 2023-02-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216903-001 11110054 2038-10-25 Drug product 2023-02-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216903-001 11938217 2038-10-25 Drug product 2024-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216903-001 10456354 2038-10-25 Drug product 2023-02-24 79d66fd596c7…
Additional Listing Data#
Finished product Yes
Brand name base PREVDUO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEOSTIGMINE METHYLSULFATE .2 mg/mL GLYCOPYRROLATE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98IMH7M386 Internal UNII lookup 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 2637041 Internal RxNorm lookup 2637047 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 42023-269-01 PREVDUO 3 mL in 1 SYRINGE, PLASTIC INJECTION 3 2 42023-269-05 PREVDUO 5 in 1 CARTON INJECTION 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-269 PREVDUO (NEOSTIGMINE METHYLSULFATE AND GLYCOPYRROLATE) INJECTION [ENDO USA] 2 Current NDC, 2 package rows 20241031_dd8ad38f-247b-4948-a13c-8f3a4921b4f1.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PREVDUO NEOSTIGMINE METHYLSULFATE AND GLYCOPYRROLATE Endo USA dd8ad38f-247b-4948-a13c-8f3a4921b4f1 2024-04-10 Warnings, Adverse reactions Exact identifier application applno (NDA): 216903 application number: NDA216903 ndc (product): 42023-269
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42023-269-01 42023026901 3 mL in 1 SYRINGE, PLASTIC 3 ml Historical 42023-269-05 42023026905 5 SYRINGE, PLASTIC in 1 CARTON (42023-269-05) / 3 mL in 1 SYRINGE, PLASTIC (42023-269-01) 2023-05-15 No No Current