Home NDC 63323-413 Neostigmine Methylsulfate
Product NDC 63323-413
11-digit product format 633230413
Labeler code 63323
Product ID 63323-413_1efedce1-b2c3-4652-a289-6ea596b039e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neostigmine Methylsulfate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application NDA203629
Marketing category NDA
Marketing start 2015-01-08
Substance NEOSTIGMINE METHYLSULFATE
Active strength .5 mg/mL
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203629-001 NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 N203629-002 NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 N203629-003 NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N203629-003 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 4 · 132 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 2026-10-15 13:18:30 2026-09 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203629-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203629-003 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203629-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203629-003 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203629-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203629-003 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203629-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203629-003 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203629-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203629-003 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203629-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203629-003 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203629-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203629-003 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203629-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203629-003 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203629-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203629-003 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203629-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203629-003 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203629-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203629-003 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203629-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203629-003 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203629-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203629-003 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203629-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-01-08 79d66fd596c7…
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 Neostigmine Methylsulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEOSTIGMINE METHYLSULFATE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98IMH7M386 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311935 Internal RxNorm lookup 311936 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 63323-413-01 Neostigmine Methylsulfate 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 4 63323-413-10 Neostigmine Methylsulfate 10 in 1 TRAY INJECTION, SOLUTION 10 4 63323-413-36 Neostigmine Methylsulfate 10 in 1 TRAY INJECTION, SOLUTION 10 3 63323-413-36 Neostigmine Methylsulfate 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NEOSTIGMINE METHYLSULFATE ACTIVE INGREDIENT 98IMH7M386 NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 NEOSTIGMINE METHYLSULFATE ACTIVE INGREDIENT 98IMH7M386 NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 NEOSTIGMINE ACTIVE MOIETY 3982TWQ96G NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 NEOSTIGMINE ACTIVE MOIETY 3982TWQ96G NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 PHENOL INACTIVE INGREDIENT 339NCG44TV NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 PHENOL INACTIVE INGREDIENT 339NCG44TV NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-413 NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20221217_6448229c-e650-47ba-bb00-cba3604502c5.zip 63323-413 NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241020_d0e11e4c-41c3-4874-b567-579db655fba3.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Neostigmine Methylsulfate NEOSTIGMINE METHYLSULFATE Fresenius Kabi USA, LLC d0e11e4c-41c3-4874-b567-579db655fba3 2024-10-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 203629 application number: NDA203629 ndc (product): 63323-413 Neostigmine Methylsulfate NEOSTIGMINE METHYLSULFATE Fresenius Kabi USA, LLC 088f96eb-20b8-48f8-ac83-329f75a44ce1 2024-01-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 203629 application number: NDA203629 Neostigmine Methylsulfate NEOSTIGMINE METHYLSULFATE Fresenius Kabi USA, LLC b0b509c3-8dc8-48cc-b7a8-16b93ad706c6 2024-01-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 203629 application number: NDA203629 Neostigmine Methylsulfate NEOSTIGMINE METHYLSULFATE Fresenius Kabi USA, LLC 6448229c-e650-47ba-bb00-cba3604502c5 2022-12-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 203629 application number: NDA203629 ndc (product): 63323-413
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 63323-413-01 63323041301 10 mL in 1 VIAL, MULTI-DOSE 10 ml Historical 63323-413-10 63323041310 10 VIAL, MULTI-DOSE in 1 TRAY (63323-413-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-413-01) 2015-01-08 0000-00-00 No No Current 63323-413-36 63323041336 10 VIAL, MULTI-DOSE in 1 TRAY (63323-413-36) / 10 mL in 1 VIAL, MULTI-DOSE 2015-01-08 0000-00-00 No No Current