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United States · US · US:71610-757_9f1cfdaf-a07f-4f37-9f9c-695cafe6cfee
GABAPENTIN
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11716107575360 CAPSULE in 1 BOTTLE (71610-757-53)
- ndc11716107576090 CAPSULE in 1 BOTTLE (71610-757-60)
- ndc117161075780180 CAPSULE in 1 BOTTLE (71610-757-80)
- ndc117161075794360 CAPSULE in 1 BOTTLE (71610-757-94)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A214956
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": "71610-757_9f1cfdaf-a07f-4f37-9f9c-695cafe6cfee",
"productndc": "71610-757",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "214956",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "May 10, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "May 10, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "May 10, 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": "ANDA214956",
"marketing_category": "ANDA",
"nonproprietary_name": "gabapentin",
"start_marketing_date": "20210510",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code N02BF01.
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