FDA.reportPublic FDA data

NDC 0121-4675-05 - VALPROIC ACID

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0121-4675
Requested NDC
0121-4675-05
Package NDCs from labels
0121-4675-05, 0121-4675-40, 0121-4675-00
Manufacturer
PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date
2025-01-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VALPROIC ACIDPAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma2025-01-24HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-4675-00VALPROIC ACID10 in 1 TRAYSOLUTION1021
0121-4675-00VALPROIC ACID10 in 1 CASESOLUTION1021
0121-4675-05VALPROIC ACID5 mL in 1 CUP, UNIT-DOSESOLUTION521
0121-4675-40VALPROIC ACID10 in 1 TRAYSOLUTION1021
0121-4675-40VALPROIC ACID4 in 1 CASESOLUTION421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-4675VALPROIC ACID SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]21Current NDC, Legacy NDC, 5 package rows20250205_7d5cb52e-37dd-4dfa-a6f4-09f9548846c6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4675-00ML - Milliliter0121-4675d4cb1f92-9fc7-49c7-8305-259e6a62ff5612017-08-11
0121-4675-05ML - Milliliter0121-46757721a5c8-b81d-4ac4-af21-ba882ec53c9212013-02-13
0121-4675-10ML - Milliliter0121-4675c25e6ad4-cc43-4061-9178-0e9d389b666312013-02-13
0121-4675-40ML - Milliliter0121-46756da9fdac-26ec-4a1e-925c-4de7c110ac2412017-08-11
0121-4675-55ML - Milliliter0121-4675e1bac19f-eb9b-429b-a1ef-ef2ab25f0bd912015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALPROIC ACIDACTIVE INGREDIENT614OI1Z5WIVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
SORBITOLINACTIVE INGREDIENT506T60A25RVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
SUCROSEINACTIVE INGREDIENTC151H8M554VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 32 · 636 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: PDC6A3C0OX
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
unii: PDC6A3C0OX
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
unii: PDC6A3C0OX
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: PDC6A3C0OX
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: PDC6A3C0OX
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: XF417D3PSL
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: XF417D3PSL
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: XF417D3PSL
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.