FDA.reportPublic FDA data

Methylprednisolone Sodium Succinate

Product NDC
0143-9753
11-digit product format
001439753
Labeler code
0143
Product ID
0143-9753_d67a1656-c53e-45f8-9219-05a53737947f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone Sodium Succinate
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA203125
Marketing category
ANDA
Marketing start
2022-09-26
Substance
METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength
40 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methylprednisolone Sodium Succinate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE SODIUM SUCCINATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLEC9GKY20K
Rxcui311659, 1743704

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9753-01Methylprednisolone Sodium Succinate1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION15
0143-9753-25Methylprednisolone Sodium Succinate25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9753-01EA - Each0143-9753052fa752-4d7b-47be-9777-6eb8b057715712026-05-22
0143-9753-25EA - Each0143-9753d5af43c3-600f-4a46-b36e-69fa94ca14e812023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9753METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, 2 package rows20250302_05d95a56-b03a-4d5b-9877-2853ac470fa1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSN05d95a56-b03a-4d5b-9877-2853ac470fa15
311659methylPREDNISolone sodium succinate 40 MG InjectionPSN05d95a56-b03a-4d5b-9877-2853ac470fa15
1743704methylprednisolone 125 MG InjectionSCD05d95a56-b03a-4d5b-9877-2853ac470fa15
311659methylprednisolone 40 MG InjectionSCD05d95a56-b03a-4d5b-9877-2853ac470fa15
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSY05d95a56-b03a-4d5b-9877-2853ac470fa15
311659methylprednisolone (as methylprednisolone sodium succinate) 40 MG InjectionSY05d95a56-b03a-4d5b-9877-2853ac470fa15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0143-9753-01001439753011 in 1 VIAL, SINGLE-DOSEHistorical
0143-9753-250014397532525 VIAL, SINGLE-DOSE in 1 CARTON (0143-9753-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9753-01) 2022-09-26NoNoHistorical