Gabapentin

Orange BookUNIISPLATC N02BF01

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN02BF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7120593000
100 CAPSULE in 1 BOTTLE (71205-930-00)
ndc11
7120593030
30 CAPSULE in 1 BOTTLE (71205-930-30)
ndc11
7120593055
500 CAPSULE in 1 BOTTLE (71205-930-55)
ndc11
7120593060
60 CAPSULE in 1 BOTTLE (71205-930-60)
ndc11
7120593064
240 CAPSULE in 1 BOTTLE (71205-930-64)
ndc11
7120593067
270 CAPSULE in 1 BOTTLE (71205-930-67)
ndc11
7120593072
120 CAPSULE in 1 BOTTLE (71205-930-72)
ndc11
7120593076
360 CAPSULE in 1 BOTTLE (71205-930-76)
ndc11
7120593078
180 CAPSULE in 1 BOTTLE (71205-930-78)
ndc11
7120593090
90 CAPSULE in 1 BOTTLE (71205-930-90)

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": "71205-930_dc28cbd4-d236-4c09-93e9-a6088c0d2b4a",
  "productndc": "71205-930",
  "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": "400"
}

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