FDA.reportPublic FDA data

Neostigmine Methylsulfate

Product NDC
0641-6149
11-digit product format
006416149
Labeler code
0641
Product ID
0641-6149_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
1 mg/mL
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOSTIGMINE METHYLSULFATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98IMH7M386
Rxcui311935, 311936

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
0641-6149-01Neostigmine Methylsulfate10 mL in 1 VIAL, MULTI-DOSEINJECTION1012
0641-6149-10Neostigmine Methylsulfate10 in 1 CARTONINJECTION1012
0641-6149-25Neostigmine Methylsulfate25 in 1 CARTONINJECTION2512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6149-01ML - Milliliter0641-61497896f979-9bee-4d58-9369-3333f2ae6faa12016-01-13
0641-6149-10ML - Milliliter0641-6149f69b7c8d-d64e-4648-a25d-0de2bf57aef612016-01-13
0641-6149-25ML - Milliliter0641-61498984c457-bda3-4651-907b-1caef1a8aa0212016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6149NEOSTIGMINE METHYLSULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 3 package rows20240410_7a9d996f-aecb-455f-95fc-1010e461d75d.zip

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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6149-010064161490110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
0641-6149-100064161491010 VIAL, MULTI-DOSE in 1 CARTON (0641-6149-10) / 10 mL in 1 VIAL, MULTI-DOSE (0641-6149-01) 2015-12-280000-00-00NoNoCurrent
0641-6149-250064161492525 VIAL, MULTI-DOSE in 1 CARTON (0641-6149-25) > 10 mL in 1 VIAL, MULTI-DOSE (0641-6149-01) 2015-12-280000-00-00NoNoCurrent