Gabapentin

Orange BookUNIISPLATC N02BF01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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 · 8

ndc11
7161004430
30 TABLET, FILM COATED in 1 BOTTLE (71610-044-30)
ndc11
7161004445
45 TABLET, FILM COATED in 1 BOTTLE (71610-044-45)
ndc11
7161004453
60 TABLET, FILM COATED in 1 BOTTLE (71610-044-53)
ndc11
7161004460
90 TABLET, FILM COATED in 1 BOTTLE (71610-044-60)
ndc11
7161004470
120 TABLET, FILM COATED in 1 BOTTLE (71610-044-70)
ndc11
7161004473
135 TABLET, FILM COATED in 1 BOTTLE (71610-044-73)
ndc11
7161004480
180 TABLET, FILM COATED in 1 BOTTLE (71610-044-80)
ndc11
7161004492
270 TABLET, FILM COATED in 1 BOTTLE (71610-044-92)

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": "71610-044_a695e055-6531-4b51-969f-62165d703511",
  "productndc": "71610-044",
  "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"
}

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