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United States · US · US:42192-608_42b42328-c02f-5413-e063-6394a90ace67
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAcella Pharmaceuticals, LLC
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1142192608055 mL in 1 CUP, UNIT-DOSE (42192-608-05)
- ndc1142192608066 mL in 1 CUP, UNIT-DOSE (42192-608-06)
- ndc114219260816470 mL in 1 BOTTLE (42192-608-16)
- ndc11421926084040 CUP, UNIT-DOSE in 1 BOX (42192-608-40) / 6 mL in 1 CUP, UNIT-DOSE
- ndc11421926084540 CUP, UNIT-DOSE in 1 BOX (42192-608-45) / 5 mL in 1 CUP, UNIT-DOSE
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A076403
AA
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": "42192-608_42b42328-c02f-5413-e063-6394a90ace67",
"productndc": "42192-608",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "076403",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "250MG/5ML",
"product_no": "001",
"approval_date": "May 1, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA076403",
"marketing_category": "ANDA",
"nonproprietary_name": "gabapentin",
"start_marketing_date": "20121001",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code N02BF01.
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