methylprednisolone

Generic: methylprednisolone

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylprednisolone
Generic Name methylprednisolone
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methylprednisolone 16 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1350
Product ID 70771-1350_99239c7c-b107-454a-8cee-9dd6cbd5647b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206751
Listing Expiration 2026-12-31
Marketing Start 2018-05-01

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711350
Hyphenated Format 70771-1350

Supplemental Identifiers

RxCUI
197971 197973 259966 328161
UPC
0368382919113
UNII
X4W7ZR7023
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name methylprednisolone (source: ndc)
Generic Name methylprednisolone (source: ndc)
Application Number ANDA206751 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 16 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70771-1350-1)
  • 10 BLISTER PACK in 1 CARTON (70771-1350-4) / 10 TABLET in 1 BLISTER PACK (70771-1350-2)
  • 500 TABLET in 1 BOTTLE (70771-1350-5)
  • 50 TABLET in 1 BOTTLE (70771-1350-7)
source: ndc

Packages (4)

70771-1350-1 100 TABLET in 1 BOTTLE (70771-1350-1) 70771-1350-4 10 BLISTER PACK in 1 CARTON (70771-1350-4) / 10 TABLET in 1 BLISTER PACK (70771-1350-2) 70771-1350-5 500 TABLET in 1 BOTTLE (70771-1350-5) 70771-1350-7 50 TABLET in 1 BOTTLE (70771-1350-7)

Ingredients (1)

methylprednisolone (16 mg/1)

Linked Drug Pages (1)

methylprednisolone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "99239c7c-b107-454a-8cee-9dd6cbd5647b", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0368382919113"], "unii": ["X4W7ZR7023"], "rxcui": ["197971", "197973", "259966", "328161"], "spl_set_id": ["fe9c15b5-4264-45f1-87b5-f7e1d6e6ddee"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1350-1)", "package_ndc": "70771-1350-1", "marketing_start_date": "20180501"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1350-4)  / 10 TABLET in 1 BLISTER PACK (70771-1350-2)", "package_ndc": "70771-1350-4", "marketing_start_date": "20180501"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70771-1350-5)", "package_ndc": "70771-1350-5", "marketing_start_date": "20180501"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE (70771-1350-7)", "package_ndc": "70771-1350-7", "marketing_start_date": "20180501"}], "brand_name": "methylprednisolone", "product_id": "70771-1350_99239c7c-b107-454a-8cee-9dd6cbd5647b", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70771-1350", "generic_name": "methylprednisolone", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "methylprednisolone", "active_ingredients": [{"name": "METHYLPREDNISOLONE", "strength": "16 mg/1"}], "application_number": "ANDA206751", "marketing_category": "ANDA", "marketing_start_date": "20180501", "listing_expiration_date": "20261231"}