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United States · US · US:81033-123_3f2ba3d6-6087-eaf2-e063-6294a90a7642
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKesin Pharma Corporation
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11810331234440 CUP, UNIT-DOSE in 1 CARTON (81033-123-44) / 5 mL in 1 CUP, UNIT-DOSE (81033-123-05)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A091286
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6CW7F3G59X",
"rxcui": "25480",
"inchikey": "UGJMXCAKCUNAIE-UHFFFAOYSA-N",
"display_name": "GABAPENTIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"798575b9-ddfa-4915-9574-626abbaf025f": {
"match": "brand_token",
"title": "GABAPENTIN CAPSULE [STRIDES PHARMA SCIENCE LIMITED]",
"spl_version": "3",
"published_date": "2026-06-02"
}
},
"productid": "81033-123_3f2ba3d6-6087-eaf2-e063-6294a90a7642",
"productndc": "81033-123",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "091286",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "250MG/5ML",
"product_no": "001",
"approval_date": "Mar 14, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA091286",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20250806",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N02BF01.
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