valproic acid
Generic: valproic acid
Labeler: xttrium laboratories inc.Drug Facts
Product Profile
Brand Name
valproic acid
Generic Name
valproic acid
Labeler
xttrium laboratories inc.
Dosage Form
SOLUTION
Routes
Active Ingredients
valproic acid 250 mg/5mL
Manufacturer
Identifiers & Regulatory
Product NDC
0116-4021
Product ID
0116-4021_3b124fef-0b53-8f72-e063-6394a90a81c4
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA070868
Listing Expiration
2026-12-31
Marketing Start
1986-07-01
Pharmacologic Class
Established (EPC)
Physiologic Effect
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
01164021
Hyphenated Format
0116-4021
Supplemental Identifiers
RxCUI
UNII
NUI
Packaging Origin
Original Packager
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
ANDA070868 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 250 mg/5mL
Packaging
- 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)
- 473 mL in 1 BOTTLE, PLASTIC (0116-4021-16)
- 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)
- 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)
Packages (4)
0116-4021-11
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)
0116-4021-16
473 mL in 1 BOTTLE, PLASTIC (0116-4021-16)
0116-4021-40
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)
0116-4021-41
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)
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3b124fef-0b53-8f72-e063-6394a90a81c4", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751"], "unii": ["614OI1Z5WI"], "rxcui": ["1099687"], "spl_set_id": ["3b124a29-30bd-d30e-e063-6294a90ac4ca"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]", "Mood Stabilizer [EPC]"], "manufacturer_name": ["Xttrium Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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)", "package_ndc": "0116-4021-11", "marketing_start_date": "20250729"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (0116-4021-16)", "package_ndc": "0116-4021-16", "marketing_start_date": "20250729"}, {"sample": false, "description": "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)", "package_ndc": "0116-4021-40", "marketing_start_date": "20250729"}, {"sample": false, "description": "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)", "package_ndc": "0116-4021-41", "marketing_start_date": "20250729"}], "brand_name": "Valproic Acid", "product_id": "0116-4021_3b124fef-0b53-8f72-e063-6394a90a81c4", "dosage_form": "SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "0116-4021", "generic_name": "Valproic Acid", "labeler_name": "Xttrium Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valproic Acid", "active_ingredients": [{"name": "VALPROIC ACID", "strength": "250 mg/5mL"}], "application_number": "ANDA070868", "marketing_category": "ANDA", "marketing_start_date": "19860701", "listing_expiration_date": "20261231"}