Methylprednisolone Sodium Succinate

Product NDC
70121-1001
11-digit product format
701211001
Labeler code
70121
Product ID
70121-1001_3eb27de6-9e1c-4ef4-bb31-2458b9360582
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA207549
Marketing category
ANDA
Marketing start
2016-11-11
Substance
METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength
125 mg/2mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methylprednisolone Sodium Succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE SODIUM SUCCINATE125 mg/2mL

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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1001-1Methylprednisolone Sodium Succinate2 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,224
70121-1001-5Methylprednisolone Sodium Succinate25 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,2524

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1001-1EA - Each70121-1001f2656701-d84e-4790-bc60-9e4e107214f312017-04-05
70121-1001-5EA - Each70121-1001b5305c20-93b6-4995-bff2-19d2a34e5e9c12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1001METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]23Current NDC, Legacy NDC, 2 package rows20240805_e86fbda8-00e4-4d54-841a-59dea6c15e70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSNe86fbda8-00e4-4d54-841a-59dea6c15e7024
311659methylPREDNISolone sodium succinate 40 MG InjectionPSNe86fbda8-00e4-4d54-841a-59dea6c15e7024
1743704methylprednisolone 125 MG InjectionSCDe86fbda8-00e4-4d54-841a-59dea6c15e7024
311659methylprednisolone 40 MG InjectionSCDe86fbda8-00e4-4d54-841a-59dea6c15e7024
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSYe86fbda8-00e4-4d54-841a-59dea6c15e7024
311659methylprednisolone (as methylprednisolone sodium succinate) 40 MG InjectionSYe86fbda8-00e4-4d54-841a-59dea6c15e7024

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1001-1701211001012 mL in 1 VIAL2 mlHistorical
70121-1001-57012110010525 VIAL in 1 CARTON (70121-1001-5) / 2 mL in 1 VIAL (70121-1001-1) 25 vial2016-11-110000-00-00NoNoCurrent