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United States · US · US:50228-464_e90bfe09-9adb-03c0-e053-2a95a90a061e
Pregabalin Extended Release
Orange BookUNIISPLATC N02BF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerScieGen Pharmaceuticals, INC.
CountryUS (United States)
ATC codeN02BF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115022846405500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-464-05)
- ndc11502284643030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-464-30)
Annotations
UNII (FDA Substance ID)
55JG375S6M
PREGABALIN
RxCUI 187832
Orange Book
A215675
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": "50228-464_e90bfe09-9adb-03c0-e053-2a95a90a061e",
"productndc": "50228-464",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "215675",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "82.5MG",
"product_no": "001",
"approval_date": "Sep 14, 2022"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "165MG",
"product_no": "002",
"approval_date": "Sep 14, 2022"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "330MG",
"product_no": "003",
"approval_date": "Sep 14, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PREGABALIN",
"proprietary_name": "Pregabalin Extended Release",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215675",
"marketing_category": "ANDA",
"nonproprietary_name": "PREGABALIN",
"start_marketing_date": "20220914",
"active_numerator_strength": "330"
}Related drugs
Other records sharing ATC code N02BF02.
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