Neostigmine Methylsulfate

Product NDC
76045-214
11-digit product format
760450214
Labeler code
76045
Product ID
76045-214_27e94d4f-f8d8-437a-a770-7020a9f8f61d
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
2018-09-18
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

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 Identifiers#

Field, Values table
FieldValues
Unii98IMH7M386
Rxcui2105413

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
76045-214-00Neostigmine Methylsulfate3 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION316
76045-214-00Neostigmine Methylsulfate1 in 1 BLISTER PACKINJECTION, SOLUTION116
76045-214-30Neostigmine Methylsulfate10 in 1 CARTONINJECTION, SOLUTION1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76045-214-00ML - Milliliter76045-2144a37f3df-29d5-4733-a505-82d3a4ace0ff12025-02-10
76045-214-30ML - Milliliter76045-214e3e8fa40-fe62-4d90-9ad4-5475a7e278f412025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76045-214NEOSTIGMINE METHYLSULFATE (NEOSTIGMINE METHYLSULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]16Current NDC, Legacy NDC, 3 package rows20240119_b0b509c3-8dc8-48cc-b7a8-16b93ad706c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2105413neostigmine methylsulfate 3 MG in 3 ML Prefilled SyringePSNb0b509c3-8dc8-48cc-b7a8-16b93ad706c616
21054133 ML neostigmine methylsulfate 1 MG/ML Prefilled SyringeSCDb0b509c3-8dc8-48cc-b7a8-16b93ad706c616
2105413neostigmine methylsulfate 3 MG per 3 ML Prefilled SyringeSYb0b509c3-8dc8-48cc-b7a8-16b93ad706c616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76045-214-00760450214003 mL in 1 SYRINGE, GLASS3 mlHistorical
76045-214-307604502143010 BLISTER PACK in 1 CARTON (76045-214-30) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-214-00) / 3 mL in 1 SYRINGE, GLASS10 blister pack2022-06-010000-00-00NoNoCurrent