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United States · US · US:43353-085_a83d04b7-84f7-4967-9721-a82a0fe8d83e

valproic acid

Orange BookUNIISPLATC N03AG01

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

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
    4335308553
    60 CAPSULE in 1 BOTTLE (43353-085-53)
  • ndc11
    4335308560
    90 CAPSULE in 1 BOTTLE (43353-085-60)
  • ndc11
    4335308570
    120 CAPSULE in 1 BOTTLE (43353-085-70)
  • ndc11
    4335308580
    180 CAPSULE in 1 BOTTLE (43353-085-80)
  • ndc11
    4335308590
    240 CAPSULE in 1 BOTTLE (43353-085-90)
  • ndc11
    4335308594
    360 CAPSULE in 1 BOTTLE (43353-085-94)

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": "43353-085_a83d04b7-84f7-4967-9721-a82a0fe8d83e",
  "productndc": "43353-085",
  "dosage_form": "CAPSULE",
  "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 acid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA073229",
  "marketing_category": "ANDA",
  "nonproprietary_name": "valproic acid",
  "start_marketing_date": "20111029",
  "active_numerator_strength": "250"
}

Related drugs

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