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United States · US · US:70518-3805_3b298edc-34ee-b535-e063-6294a90a56f2

VALPROIC ACID

Orange BookUNIISPLATC N03AG01

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeN03AG01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7051838050
    10 CUP, UNIT-DOSE in 1 BOX (70518-3805-0) / 5 mL in 1 CUP, UNIT-DOSE (70518-3805-1)
  • ndc11
    7051838052
    10 CUP, UNIT-DOSE in 1 BOX (70518-3805-2) / 10 mL in 1 CUP, UNIT-DOSE (70518-3805-3)

Annotations

UNII (FDA Substance ID)
614OI1Z5WI
VALPROIC ACID
RxCUI 11118
Orange Book
A075379
AA
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": "70518-3805_3b298edc-34ee-b535-e063-6294a90a56f2",
  "productndc": "70518-3805",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "075379",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "250MG/5ML",
        "product_no": "001",
        "approval_date": "Dec 15, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VALPROIC ACID",
  "proprietary_name": "VALPROIC ACID",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA075379",
  "marketing_category": "ANDA",
  "nonproprietary_name": "VALPROIC ACID",
  "start_marketing_date": "20230725",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code N03AG01.

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