Valproic Acid

Orange BookUNIISPLATC N03AG01

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeN03AG01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
4335327953
60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-53)
ndc11
4335327960
90 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-60)
ndc11
4335327970
120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-70)
ndc11
4335327980
180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-80)
ndc11
4335327990
240 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-90)
ndc11
4335327994
360 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-94)

Annotations

UNII (FDA Substance ID)

614OI1Z5WI

VALPROIC ACID

RxCUI 11118

Orange Book

A073484

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "614OI1Z5WI",
    "rxcui": "11118",
    "inchikey": "NIJJYAXOARWZEE-UHFFFAOYSA-N",
    "display_name": "VALPROIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ceb52870-76d0-4108-a1d4-ba7096fbacdd": {
      "match": "brand_token",
      "title": "VALPROIC ACID CAPSULE, LIQUID FILLED [BIONPHARMA INC.]",
      "spl_version": "13",
      "published_date": "2026-06-01"
    }
  },
  "productid": "43353-279_1f5efbea-ccd0-4213-9324-769b0077144f",
  "productndc": "43353-279",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "073484",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jun 29, 1993"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VALPROIC ACID",
  "proprietary_name": "Valproic Acid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA073484",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valproic Acid",
  "start_marketing_date": "20160715",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code N03AG01.

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