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United States · US · US:59762-1576_7aa334e7-3c46-4680-a266-9049af3bf566
Pregabalin
Orange BookUNIISPLATC N02BF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN02BF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159762157611 BOTTLE in 1 CARTON (59762-1576-1) / 473 mL in 1 BOTTLE
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": {
"34846423-e747-42c5-9bcd-f99c557c4f67": {
"match": "brand_token",
"title": "PREGABALIN CAPSULE [PROFICIENT RX LP]",
"spl_version": "1",
"published_date": "2026-05-29"
}
},
"productid": "59762-1576_7aa334e7-3c46-4680-a266-9049af3bf566",
"productndc": "59762-1576",
"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": "Pregabalin",
"active_ingred_unit": "mg/mL",
"application_number": "NDA022488",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Pregabalin",
"start_marketing_date": "20190729",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N02BF02.
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