Neostigmine Methylsulfate

Product NDC
0641-6150
Requested package NDC
0641-6150-25
11-digit product format
006416150
Labeler code
0641
Product ID
0641-6150_c40a77c1-5b7e-4f38-bb27-d8a56ddd9084
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neostigmine Methylsulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA207042
Marketing category
ANDA
Marketing start
2015-12-28
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0641-61500641-6150-25DDiscontinued by firm2026-08-11

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
A207042-001NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRS2015-12-28
A207042-002NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRS2015-12-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A207042-001AP
A207042-002AP

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRS2015-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRS2015-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207042-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A207042-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2015-12-28782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207042-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207042-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207042-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207042-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207042-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207042-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207042-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207042-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207042-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207042-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207042-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207042-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207042-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207042-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207042-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207042-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207042-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207042-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207042-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207042-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207042-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207042-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207042-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207042-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207042-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207042-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207042-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207042-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207042-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207042-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207042-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207042-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207042-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207042-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207042-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207042-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207042-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207042-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207042-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207042-002AP1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Neostigmine Methylsulfate
Listing expiration
2027-12-31

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
7a9d996f-aecb-455f-95fc-1010e461d75dAvailable 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
0641-6150-01Neostigmine Methylsulfate10 mL in 1 VIAL, MULTI-DOSEINJECTION1012
0641-6150-10Neostigmine Methylsulfate10 in 1 CARTONINJECTION1012
0641-6150-25Neostigmine Methylsulfate25 in 1 CARTONINJECTION2512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6150-01ML - Milliliter0641-61504a4ee9f8-ecbe-40e7-9394-57467a17c26412016-01-13
0641-6150-10ML - Milliliter0641-6150681b226b-e984-453a-b54e-d8dab3e68ccb12016-01-13
0641-6150-25ML - Milliliter0641-6150b3c203f5-f744-4184-b2df-5624c61ceaf212016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6150NEOSTIGMINE METHYLSULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 3 package rows20240410_7a9d996f-aecb-455f-95fc-1010e461d75d.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neostigmine MethylsulfateNEOSTIGMINE METHYLSULFATEHikma Pharmaceuticals USA Inc.7a9d996f-aecb-455f-95fc-1010e461d75d2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207042
application number: ANDA207042
ndc (package): 0641-6150-25
ndc (product): 0641-6150
ndc11 (package): 00641615025
Neostigmine MethylsulfateNEOSTIGMINE METHYLSULFATECivica, Inc.454d54dc-b803-4519-81e8-ac7d21e6aae12024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207042
application number: ANDA207042
Neostigmine MethylsulfateNEOSTIGMINE METHYLSULFATEHikma Pharmaceuticals USA Inc.28365ed5-8332-48ac-a93d-b165ac3c6eac2024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207042
application number: ANDA207042
Neostigmine MethylsulfateNEOSTIGMINE METHYLSULFATEHikma Pharmaceuticals USA Inc.f6b466a7-817c-4cb6-ac58-1b3bbf0531df2024-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207042
application number: ANDA207042

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionPSN7a9d996f-aecb-455f-95fc-1010e461d75d12
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionPSN7a9d996f-aecb-455f-95fc-1010e461d75d12
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSCD7a9d996f-aecb-455f-95fc-1010e461d75d12
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSCD7a9d996f-aecb-455f-95fc-1010e461d75d12
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSY7a9d996f-aecb-455f-95fc-1010e461d75d12
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSY7a9d996f-aecb-455f-95fc-1010e461d75d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0641-6150-250064161502525 VIAL, MULTI-DOSE in 1 CARTON (0641-6150-25) > 10 mL in 1 VIAL, MULTI-DOSE (0641-6150-01) 2015-12-280000-00-00NoNoCurrent