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United States · US · US:0591-4012_8c8b8043-7c2a-44cc-80e7-fdfa0236287e

Valproic

Orange BookUNIISPLATC N03AG01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeN03AG01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0591401201
    100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0591-4012-01)

Annotations

UNII (FDA Substance ID)
614OI1Z5WI
VALPROIC ACID
RxCUI 11118
Orange Book
A073229
AB
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": "0591-4012_8c8b8043-7c2a-44cc-80e7-fdfa0236287e",
  "productndc": "0591-4012",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "073229",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Oct 29, 1991"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VALPROIC ACID",
  "proprietary_name": "Valproic",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA073229",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valproic Acid",
  "start_marketing_date": "20090908",
  "active_numerator_strength": "250"
}

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