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United States · US · US:76420-789_227219b4-ec12-cb15-e063-6394a90acd32
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc117642078901100 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-01)
- ndc117642078905500 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-05)
- ndc117642078912120 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-12)
- ndc11764207893030 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-30)
- ndc11764207896060 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-60)
- ndc11764207899090 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-90)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A204989
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": "76420-789_227219b4-ec12-cb15-e063-6394a90acd32",
"productndc": "76420-789",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204989",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Feb 18, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Feb 18, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Feb 18, 2016"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "004",
"approval_date": "Mar 6, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204989",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20160218",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N02BF01.
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