FDA.reportPublic FDA data

Methylprednisolone acetate

Product NDC
70121-1552
11-digit product format
701211552
Labeler code
70121
Product ID
70121-1552_f352a878-91a5-455d-a7b4-8180aac9d1fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA210043
Marketing category
ANDA
Marketing start
2021-11-01
Substance
METHYLPREDNISOLONE ACETATE
Active strength
80 mg/mL
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 acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE ACETATE80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii43502P7F0P
Rxcui1743855

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1552-1Methylprednisolone acetate1 in 1 CARTONINJECTION, SUSPENSION16
70121-1552-1Methylprednisolone acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION16
70121-1552-5Methylprednisolone acetate25 in 1 CARTONINJECTION, SUSPENSION256
70121-1552-5Methylprednisolone acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1552-1ML - Milliliter70121-1552e287dba2-841c-4f66-b21c-2757ab000a3612022-03-09
70121-1552-5ML - Milliliter70121-1552643f67ce-b6ed-42da-b159-6329a710ca6c12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1552METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [AMNEAL PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 4 package rows20250108_3184a75e-61c5-4281-abf0-4eab861ca009.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSN3184a75e-61c5-4281-abf0-4eab861ca0096
17438551 ML methylprednisolone acetate 80 MG/ML InjectionSCD3184a75e-61c5-4281-abf0-4eab861ca0096
1743855methylprednisolone acetate 80 MG per 1 ML InjectionSY3184a75e-61c5-4281-abf0-4eab861ca0096

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70121-1552-1701211552011 VIAL, SINGLE-DOSE in 1 CARTON (70121-1552-1) / 1 mL in 1 VIAL, SINGLE-DOSE2021-11-010000-00-00NoNoCurrent
70121-1552-57012115520525 VIAL, SINGLE-DOSE in 1 CARTON (70121-1552-5) / 1 mL in 1 VIAL, SINGLE-DOSE2021-11-010000-00-00NoNoCurrent