valproic acid

Generic: valproic acid

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valproic acid
Generic Name valproic acid
Labeler northstar rx llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

valproic acid 250 mg/5mL

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 72603-253
Product ID 72603-253_1286acbf-3497-5aed-e063-6294a90af8be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073178
Listing Expiration 2026-12-31
Marketing Start 2024-06-10

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 72603253
Hyphenated Format 72603-253

Supplemental Identifiers

RxCUI
1099687
UNII
614OI1Z5WI
NUI
N0000175753 N0000008486 N0000175751

Packaging Origin

Original Packager
true

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 ANDA073178 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (72603-253-01)
source: ndc

Packages (1)

72603-253-01 473 mL in 1 BOTTLE (72603-253-01)

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": "1286acbf-3497-5aed-e063-6294a90af8be", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751"], "unii": ["614OI1Z5WI"], "rxcui": ["1099687"], "spl_set_id": ["1286ab49-fa34-488e-e063-6394a90ad582"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]", "Mood Stabilizer [EPC]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (72603-253-01)", "package_ndc": "72603-253-01", "marketing_start_date": "20240610"}], "brand_name": "Valproic Acid", "product_id": "72603-253_1286acbf-3497-5aed-e063-6294a90af8be", "dosage_form": "SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "72603-253", "generic_name": "Valproic Acid", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valproic Acid", "active_ingredients": [{"name": "VALPROIC ACID", "strength": "250 mg/5mL"}], "application_number": "ANDA073178", "marketing_category": "ANDA", "marketing_start_date": "20240610", "listing_expiration_date": "20261231"}