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United States · US · US:83008-063_f29d6f9a-6f31-40d2-afed-56b35eeea612
GABAPENTIN
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerQuality Care Products, LLC
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11830080636060 TABLET in 1 BOTTLE (83008-063-60)
- ndc11830080639090 TABLET in 1 BOTTLE (83008-063-90)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A214957
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": "83008-063_f29d6f9a-6f31-40d2-afed-56b35eeea612",
"productndc": "83008-063",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214957",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "600MG",
"product_no": "001",
"approval_date": "Oct 1, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "800MG",
"product_no": "002",
"approval_date": "Oct 1, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "GABAPENTIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214957",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20240610",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N02BF01.
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