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United States · US · US:68382-916_6cebff10-362f-41a7-8f66-3d9e878760fd
methylprednisolone
In shortageOrange BookUNIISPLATC H02BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeH02BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116838291601100 TABLET in 1 BOTTLE (68382-916-01)
- ndc116838291605500 TABLET in 1 BOTTLE (68382-916-05)
- ndc1168382916341 BLISTER PACK in 1 CARTON (68382-916-34) / 21 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
X4W7ZR7023
METHYLPREDNISOLONE
RxCUI 6902
Orange Book
A206751
ABABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methylprednisolone Acetate Injection
Raw payload (JSON)
{
"unii": {
"unii": "X4W7ZR7023",
"rxcui": "6902",
"inchikey": "VHRSUDSXCMQTMA-PJHHCJLFSA-N",
"display_name": "METHYLPREDNISOLONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7092df48-4904-4047-9916-e585417a216f": {
"match": "brand_token",
"title": "METHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]",
"spl_version": "3",
"published_date": "2026-05-25"
}
},
"productid": "68382-916_6cebff10-362f-41a7-8f66-3d9e878760fd",
"productndc": "68382-916",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "206751",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "4MG",
"product_no": "001",
"approval_date": "Apr 23, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "8MG",
"product_no": "002",
"approval_date": "Apr 23, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "16MG",
"product_no": "003",
"approval_date": "Apr 23, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "32MG",
"product_no": "004",
"approval_date": "Apr 23, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHYLPREDNISOLONE",
"shortage_reason": "Methylprednisolone Acetate Injection",
"shortage_status": "current",
"proprietary_name": "methylprednisolone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206751",
"marketing_category": "ANDA",
"nonproprietary_name": "methylprednisolone",
"start_marketing_date": "20180501",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code H02BX01.
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