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United States · US · US:58151-244_1c2af07d-faf4-4fc7-b724-c5166746956d
Lyrica
Orange BookUNIISPLATC N02BF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeN02BF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115815124435473 mL in 1 BOTTLE (58151-244-35)
Annotations
UNII (FDA Substance ID)
55JG375S6M
PREGABALIN
RxCUI 187832
Orange Book
N022488
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "55JG375S6M",
"rxcui": "187832",
"inchikey": "AYXYPKUFHZROOJ-ZETCQYMHSA-N",
"display_name": "PREGABALIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f280bbd8-2af2-444a-bd96-e409337ca6dd": {
"match": "brand_token",
"title": "LYRICA CR (PREGABALIN) TABLET, FILM COATED, EXTENDED RELEASE [VIATRIS SPECIALTY LLC]",
"spl_version": "7",
"published_date": "2026-04-15"
}
},
"productid": "58151-244_1c2af07d-faf4-4fc7-b724-c5166746956d",
"productndc": "58151-244",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "022488",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "20MG/ML",
"product_no": "001",
"approval_date": "Jan 4, 2010"
}
],
"appl_type": "N"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PREGABALIN",
"proprietary_name": "Lyrica",
"active_ingred_unit": "mg/mL",
"application_number": "NDA022488",
"marketing_category": "NDA",
"nonproprietary_name": "PREGABALIN",
"start_marketing_date": "20241022",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N02BF02.
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