Valproic Acid

Orange BookUNIISPLATC N03AG01

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

Identification

ManufacturerXttrium Laboratories Inc.

CountryUS (United States)

ATC codeN03AG01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
0116402111
10 TRAY in 1 CASE (0116-4021-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4021-10)
ndc11
0116402116
473 mL in 1 BOTTLE, PLASTIC (0116-4021-16)
ndc11
0116402140
4 TRAY in 1 CASE (0116-4021-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4021-05)
ndc11
0116402141
10 TRAY in 1 CASE (0116-4021-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4021-05)

Annotations

UNII (FDA Substance ID)

614OI1Z5WI

VALPROIC ACID

RxCUI 11118

Orange Book

A070868

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": "0116-4021_4459a233-1fe1-41dc-e063-6394a90a5ab4",
  "productndc": "0116-4021",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "070868",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG/5ML",
        "product_no": "001",
        "approval_date": "Jul 1, 1986"
      }
    ],
    "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": "ANDA070868",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valproic Acid",
  "start_marketing_date": "19860701",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code N03AG01.

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