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United States · US · US:39328-090_3a08157d-abaf-445c-b333-c209ef961bc0
PREGABALIN
Orange BookUNIISPLATC N02BF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPatrin Pharma, Inc.
CountryUS (United States)
ATC codeN02BF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1139328090161 BOTTLE, PLASTIC in 1 CARTON (39328-090-16) / 473 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
55JG375S6M
PREGABALIN
RxCUI 187832
Orange Book
A212604
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": "39328-090_3a08157d-abaf-445c-b333-c209ef961bc0",
"productndc": "39328-090",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "212604",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "20MG/ML",
"product_no": "001",
"approval_date": "Feb 18, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PREGABALIN",
"proprietary_name": "PREGABALIN",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA212604",
"marketing_category": "ANDA",
"nonproprietary_name": "PREGABALIN",
"start_marketing_date": "20220614",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N02BF02.
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