methylprednisolone

Generic: methylprednisolone

Labeler: tianjin tianyao pharmaceuticals co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylprednisolone
Generic Name methylprednisolone
Labeler tianjin tianyao pharmaceuticals co., ltd.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methylprednisolone 4 mg/1

Manufacturer
Tianjin Tianyao Pharmaceuticals Co., Ltd.

Identifiers & Regulatory

Product NDC 57582-101
Product ID 57582-101_925bd0e3-3f69-411c-ad1e-7db010ec17be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204072
Listing Expiration 2027-12-31
Marketing Start 2018-05-14

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 57582101
Hyphenated Format 57582-101

Supplemental Identifiers

RxCUI
259966
UPC
0357582101015 0357582101022
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 ANDA204072 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (57582-101-01)
  • 1 BLISTER PACK in 1 CARTON (57582-101-02) / 21 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

57582-101-01 100 TABLET in 1 BOTTLE (57582-101-01) 57582-101-02 1 BLISTER PACK in 1 CARTON (57582-101-02) / 21 TABLET in 1 BLISTER PACK

Ingredients (1)

methylprednisolone (4 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": "925bd0e3-3f69-411c-ad1e-7db010ec17be", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0357582101015", "0357582101022"], "unii": ["X4W7ZR7023"], "rxcui": ["259966"], "spl_set_id": ["e09eefd2-f423-40cb-87b6-3ee97e7f831b"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Tianjin Tianyao Pharmaceuticals Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (57582-101-01)", "package_ndc": "57582-101-01", "marketing_start_date": "20180514"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (57582-101-02)  / 21 TABLET in 1 BLISTER PACK", "package_ndc": "57582-101-02", "marketing_start_date": "20190214"}], "brand_name": "METHYLPREDNISOLONE", "product_id": "57582-101_925bd0e3-3f69-411c-ad1e-7db010ec17be", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "57582-101", "generic_name": "METHYLPREDNISOLONE", "labeler_name": "Tianjin Tianyao Pharmaceuticals Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHYLPREDNISOLONE", "active_ingredients": [{"name": "METHYLPREDNISOLONE", "strength": "4 mg/1"}], "application_number": "ANDA204072", "marketing_category": "ANDA", "marketing_start_date": "20180514", "listing_expiration_date": "20271231"}