valproic acid

Generic: valproic acid

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valproic acid
Generic Name valproic acid
Labeler remedyrepack inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

valproic acid 250 mg/5mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3805
Product ID 70518-3805_3b298edc-34ee-b535-e063-6294a90a56f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075379
Listing Expiration 2026-12-31
Marketing Start 2023-07-25

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc] mood stabilizer [epc]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183805
Hyphenated Format 70518-3805

Supplemental Identifiers

RxCUI
1099687
UNII
614OI1Z5WI
NUI
N0000175753 N0000008486 N0000175751

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name valproic acid (source: ndc)
Generic Name valproic acid (source: ndc)
Application Number ANDA075379 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 10 CUP, UNIT-DOSE in 1 BOX (70518-3805-0) / 5 mL in 1 CUP, UNIT-DOSE (70518-3805-1)
  • 10 CUP, UNIT-DOSE in 1 BOX (70518-3805-2) / 10 mL in 1 CUP, UNIT-DOSE (70518-3805-3)
source: ndc

Packages (2)

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

Ingredients (1)

valproic acid (250 mg/5mL)

Linked Drug Pages (1)

VALPROIC ACID ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b298edc-34ee-b535-e063-6294a90a56f2", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751"], "unii": ["614OI1Z5WI"], "rxcui": ["1099687"], "spl_set_id": ["65c1589e-c591-4b79-b75e-884c0d609ae8"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]", "Mood Stabilizer [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CUP, UNIT-DOSE in 1 BOX (70518-3805-0)  / 5 mL in 1 CUP, UNIT-DOSE (70518-3805-1)", "package_ndc": "70518-3805-0", "marketing_start_date": "20230725"}, {"sample": false, "description": "10 CUP, UNIT-DOSE in 1 BOX (70518-3805-2)  / 10 mL in 1 CUP, UNIT-DOSE (70518-3805-3)", "package_ndc": "70518-3805-2", "marketing_start_date": "20240313"}], "brand_name": "VALPROIC ACID", "product_id": "70518-3805_3b298edc-34ee-b535-e063-6294a90a56f2", "dosage_form": "SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "70518-3805", "generic_name": "VALPROIC ACID", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VALPROIC ACID", "active_ingredients": [{"name": "VALPROIC ACID", "strength": "250 mg/5mL"}], "application_number": "ANDA075379", "marketing_category": "ANDA", "marketing_start_date": "20230725", "listing_expiration_date": "20261231"}