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 2 of 32 · 636 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsExact identifier
unii: PDC6A3C0OX
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: PDC6A3C0OX
unii: 506T60A25R
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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