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 3 of 32 · 636 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC546347e5-841e-15ca-e063-6294a90a0c8b2026-06-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
unii: PDC6A3C0OX
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsExact identifier
unii: PDC6A3C0OX
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL
WALGREEN GLYCERIN ADULTGLYCERIN SUPPOSITORYWalgreens20c44346-0b29-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
unii: PDC6A3C0OX
WALGREENS GLYCERINGLYCERIN SUSPENSIONWalgreens20c44346-0b2b-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
unii: PDC6A3C0OX
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: XF417D3PSL
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
Equaline HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMUnited Natural Foods, Inc. dba UNFIbf87824a-522d-46da-81b6-e30ea11a22352026-06-11WarningsExact identifier
unii: PDC6A3C0OX
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
VALPROIC ACIDVALPROIC ACIDREMEDYREPACK INC.65c1589e-c591-4b79-b75e-884c0d609ae82026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075379
rxcui: 1099687
unii: 614OI1Z5WI
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: PDC6A3C0OX
ValproicVALPROIC ACIDActavis Pharma, Inc.cef3e335-5891-412f-89c4-79fcd2f145b72026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 614OI1Z5WI
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
Valproic AcidVALPROIC ACIDBionpharma Inc.ceb52870-76d0-4108-a1d4-ba7096fbacdd2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 614OI1Z5WI
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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