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United States · US · US:65862-199_7a45ad84-02a4-442d-8401-1a1495d084fa
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 9
- ndc116586219901100 CAPSULE in 1 BOTTLE (65862-199-01)
- ndc116586219905500 CAPSULE in 1 BOTTLE (65862-199-05)
- ndc11658621991010 BLISTER PACK in 1 CARTON (65862-199-10) / 10 CAPSULE in 1 BLISTER PACK
- ndc116586219918180 CAPSULE in 1 BOTTLE (65862-199-18)
- ndc116586219927270 CAPSULE in 1 BOTTLE (65862-199-27)
- ndc11658621993030 CAPSULE in 1 BOTTLE (65862-199-30)
- ndc11658621996060 CAPSULE in 1 BOTTLE (65862-199-60)
- ndc11658621999090 CAPSULE in 1 BOTTLE (65862-199-90)
- ndc1165862199991000 CAPSULE in 1 BOTTLE (65862-199-99)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A078787
ABABAB
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": "65862-199_7a45ad84-02a4-442d-8401-1a1495d084fa",
"productndc": "65862-199",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "078787",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jan 31, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Jan 31, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Jan 31, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078787",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20080131",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N02BF01.
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