FDA.reportPublic FDA data

NDC 50383-792-05 - 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
50383-792
Requested NDC
50383-792-05
Package NDCs from labels
50383-792-16, 50383-792-05, 50383-792-06, 50383-792-07, 50383-792-10, 50383-792-12
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2024-05-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Valproic Acid Oral Solution, USPATLANTIC BIOLOGICALS CORP.2024-05-16HUMAN PRESCRIPTION DRUG LABEL
Valproic acid - Akorn | Akorn Operating Company LLCAkorn | Akorn Operating Company LLC2022-09-13HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
50383-792-06These highlights do not include all the information needed to use VALPROIC ACID ORAL SOLUTION safely and effectively. See full prescribing information for VALPROIC ACID ORAL SOLUTION. VALPROIC ACID oral solution, USP Initial U.S. Approval: 1978
50383-792-07These highlights do not include all the information needed to use VALPROIC ACID ORAL SOLUTION safely and effectively. See full prescribing information for VALPROIC ACID ORAL SOLUTION. VALPROIC ACID oral solution, USP Initial U.S. Approval: 1978
50383-792-12These highlights do not include all the information needed to use VALPROIC ACID ORAL SOLUTION safely and effectively. See full prescribing information for VALPROIC ACID ORAL SOLUTION. VALPROIC ACID oral solution, USP Initial U.S. Approval: 1978
50383-792-16These highlights do not include all the information needed to use VALPROIC ACID ORAL SOLUTION safely and effectively. See full prescribing information for VALPROIC ACID ORAL SOLUTION. VALPROIC ACID oral solution, USP Initial U.S. Approval: 1978

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-792-05Valproic acid5 mL in 1 CUP, UNIT-DOSESOLUTION530
50383-792-06Valproic acid10 in 1 TRAYSOLUTION1030
50383-792-06Valproic acid4 in 1 CASESOLUTION430
50383-792-07Valproic acid10 in 1 CASESOLUTION1030
50383-792-07Valproic acid10 in 1 TRAYSOLUTION1030
50383-792-10Valproic acid10 mL in 1 CUP, UNIT-DOSESOLUTION1030
50383-792-12Valproic acid10 in 1 TRAYSOLUTION1030
50383-792-12Valproic acid10 in 1 CASESOLUTION1030
50383-792-16Valproic acid473 mL in 1 BOTTLESOLUTION47330

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-792VALPROIC ACID SOLUTION [AKORN]30Legacy NDC, 9 package rows20220916_84bbc23d-9bd3-4d48-9b64-d6eef64214b4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-792-05ML - Milliliter50383-7927e8554a9-6945-4fbc-8b08-abf9e98330d312014-02-04
50383-792-06ML - Milliliter50383-792104d12b5-2954-4e94-b3ab-dd9529ed38f212014-02-04
50383-792-07ML - Milliliter50383-792a2a62f03-5f98-483a-a1fb-39bc0ea8200112014-02-04
50383-792-10ML - Milliliter50383-7921fec1bef-492c-4af2-a6b5-0c0cb90dace712014-02-04
50383-792-12ML - Milliliter50383-792169ec525-6cdd-47a8-bed3-6f5206ad76e112014-02-04
50383-792-16ML - Milliliter50383-7923c1e03f9-5884-400f-bb34-9886df611bad12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALPROIC ACIDACTIVE INGREDIENT614OI1Z5WIVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
RASPBERRYINACTIVE INGREDIENT4N14V5R27WVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
SORBITOLINACTIVE INGREDIENT506T60A25RVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
SUCROSEINACTIVE INGREDIENTC151H8M554VALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
WATERINACTIVE INGREDIENT059QF0KO0RVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
VALPROIC ACIDACTIVE INGREDIENT614OI1Z5WIVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
RASPBERRYINACTIVE INGREDIENT4N14V5R27WVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
SORBITOLINACTIVE INGREDIENT506T60A25RVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
SUCROSEINACTIVE INGREDIENTC151H8M554VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
WATERINACTIVE INGREDIENT059QF0KO0RVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3

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 1 of 13 · 256 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valproic AcidVALPROIC ACIDREMEDYREPACK INC.1edd220d-d151-4177-9a29-9fee36489fb72026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099687
unii: 614OI1Z5WI
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
VALPROIC ACIDVALPROIC ACIDAmerican Health Packaging4b619f73-44e5-4a99-b425-a96cb2228c872026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099687
unii: 614OI1Z5WI
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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: 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
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: 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

Reported adverse events (FAERS/openFDA)#

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