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United States · US · US:64380-727_a4928566-6bc9-4a2a-a368-c68afc402368
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116438072701100 TABLET in 1 CONTAINER (64380-727-01)
- ndc116438072702500 TABLET in 1 CONTAINER (64380-727-02)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A203244
AB1AB1
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": "64380-727_a4928566-6bc9-4a2a-a368-c68afc402368",
"productndc": "64380-727",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203244",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "800MG",
"product_no": "001",
"approval_date": "Jul 12, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "600MG",
"product_no": "002",
"approval_date": "Jul 12, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203244",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20251110",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N02BF01.
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