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United States · US · US:71093-111_c5f1ec3b-405e-4128-882b-43559d5083e5
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerACI Healthcare USA, Inc.
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117109311104100 TABLET, FILM COATED in 1 BOTTLE (71093-111-04)
- ndc117109311105500 TABLET, FILM COATED in 1 BOTTLE (71093-111-05)
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": "71093-111_c5f1ec3b-405e-4128-882b-43559d5083e5",
"productndc": "71093-111",
"dosage_form": "TABLET, FILM COATED",
"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": "20140111",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N02BF01.
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