Neostigmine Methylsulfate

Product NDC
71872-7271
11-digit product format
718727271
Labeler code
71872
Product ID
71872-7271_facbe17e-4696-d5fe-e053-6394a90a8abe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neostigmine Methylsulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA213074
Marketing category
ANDA
Marketing start
2022-01-10
Substance
NEOSTIGMINE METHYLSULFATE
Active strength
1 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
A213074-001NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20
A213074-002NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213074-001AP
A213074-002AP

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 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-204b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-20782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213074-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2021-04-206a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213074-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2021-04-206a51e52b5d6a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213074-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213074-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213074-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213074-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213074-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213074-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213074-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213074-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213074-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213074-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213074-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213074-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213074-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213074-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213074-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213074-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213074-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213074-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213074-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213074-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213074-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213074-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213074-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213074-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213074-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213074-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213074-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213074-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213074-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213074-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213074-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213074-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213074-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213074-002AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213074-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213074-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213074-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A213074-002AP1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213074-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213074-002AP16a51e52b5d6a…

Additional Listing Data#

Finished product
Yes
Brand name base
Neostigmine Methylsulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOSTIGMINE METHYLSULFATE1 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
ea6027ca-aac5-c33a-e053-2995a90a87fcAvailable 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
71872-7271-1Neostigmine Methylsulfate1 in 1 BAGINJECTION12
71872-7271-1Neostigmine Methylsulfate10 mL in 1 VIAL, MULTI-DOSEINJECTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7271NEOSTIGMINE METHYLSULFATE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, Legacy NDC, 2 package rows20230504_ea6027ca-aac5-c33a-e053-2995a90a87fc.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 METHYLSULFATEMedical Purchasing Solutions, LLCea6027ca-aac5-c33a-e053-2995a90a87fc2023-05-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213074
application number: ANDA213074
ndc (product): 71872-7271
Neostigmine MethylsulfateNEOSTIGMINE METHYLSULFATESomerset Therapeutics, LLCea767851-b0ab-4a4c-a4b2-680ff40866362021-10-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213074
application number: ANDA213074
Neostigmine MethylsulfateNEOSTIGMINE METHYLSULFATEXellia Pharmaceuticals USA LLC398d8193-e1e8-42b5-a95a-86cde967c7d02021-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213074
application number: ANDA213074
Neostigmine MethylsulfateNEOSTIGMINE METHYLSULFATECaplin Steriles Limited11f38ea2-be55-4119-8eee-776f84c5e7f82021-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213074
application number: ANDA213074

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionPSNea6027ca-aac5-c33a-e053-2995a90a87fc2
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSCDea6027ca-aac5-c33a-e053-2995a90a87fc2
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSYea6027ca-aac5-c33a-e053-2995a90a87fc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71872-7271-1718727271011 VIAL, MULTI-DOSE in 1 BAG (71872-7271-1) / 10 mL in 1 VIAL, MULTI-DOSE2022-09-230000-00-00NoNoCurrent