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United States · US · US:71205-532_3b668584-ca03-409b-b016-10c252899d4c
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11712055321414 CAPSULE in 1 BOTTLE (71205-532-14)
- ndc11712055321515 CAPSULE in 1 BOTTLE (71205-532-15)
- ndc11712055323030 CAPSULE in 1 BOTTLE (71205-532-30)
- ndc11712055326060 CAPSULE in 1 BOTTLE (71205-532-60)
- ndc117120553272120 CAPSULE in 1 BOTTLE (71205-532-72)
- ndc11712055329090 CAPSULE in 1 BOTTLE (71205-532-90)
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": "71205-532_3b668584-ca03-409b-b016-10c252899d4c",
"productndc": "71205-532",
"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": "20160401",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N02BF01.
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