FDA.reportPublic FDA data

NEOSTIGMINE METHYLSULFATE

Product NDC
55150-348
11-digit product format
551500348
Labeler code
55150
Product ID
55150-348_84d4656a-c5f6-4a93-ae5b-bf77b1b6ec36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NEOSTIGMINE METHYLSULFATE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA213244
Marketing category
ANDA
Marketing start
2023-11-02
Substance
NEOSTIGMINE METHYLSULFATE
Active strength
.5 mg/mL
Pharmacologic classes
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213244-001NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02
A213244-002NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2023-11-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2023-11-028072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2023-11-026a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2023-11-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2023-11-021c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2023-11-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2023-11-02ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2023-11-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2023-11-02a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2023-11-02a72a2bbeb626…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213244-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUS2023-11-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213244-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2023-11-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A213244-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213244-002AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213244-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213244-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213244-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213244-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213244-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213244-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213244-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213244-002AP1a72a2bbeb626…

Additional Listing Data#

Finished product
Yes
Brand name base
NEOSTIGMINE METHYLSULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOSTIGMINE METHYLSULFATE.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98IMH7M386Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311935Internal RxNorm lookup
311936Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c5729883-88d7-40fe-8fe4-fe39204ccb30Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80bProduct name120231002
6c2b16d0-96e9-444e-98c5-9883cd6eb72dProduct name220230316
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ad279e69-d021-f6bd-1150-2b55f23832d5Product name920211014
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-348-01NEOSTIGMINE METHYLSULFATE10 mL in 1 VIAL, MULTI-DOSEINJECTION102
55150-348-10NEOSTIGMINE METHYLSULFATE10 in 1 CARTONINJECTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-348NEOSTIGMINE METHYLSULFATE INJECTION [EUGIA US LLC]2Current NDC, 2 package rows20240911_c5729883-88d7-40fe-8fe4-fe39204ccb30.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATEEugia US LLCc5729883-88d7-40fe-8fe4-fe39204ccb302024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213244
application number: ANDA213244
ndc (product): 55150-348

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionPSNc5729883-88d7-40fe-8fe4-fe39204ccb302
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionPSNc5729883-88d7-40fe-8fe4-fe39204ccb302
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSCDc5729883-88d7-40fe-8fe4-fe39204ccb302
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSCDc5729883-88d7-40fe-8fe4-fe39204ccb302
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSYc5729883-88d7-40fe-8fe4-fe39204ccb302
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSYc5729883-88d7-40fe-8fe4-fe39204ccb302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55150-348-015515003480110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
55150-348-105515003481010 VIAL, MULTI-DOSE in 1 CARTON (55150-348-10) / 10 mL in 1 VIAL, MULTI-DOSE (55150-348-01) 2023-11-02NoNoCurrent