FDA.reportPublic FDA data

NDC 51079-241-01 - Acamprosate Calcium

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
51079-241
Requested NDC
51079-241-01
Package NDCs from labels
51079-241-01, 51079-241-06
Manufacturer
Mylan Institutional Inc.
Effective date
2020-06-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acamprosate Calcium - Mylan Institutional Inc.Mylan Institutional Inc.2020-06-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-241-01EA - Each51079-241a2dabd71-5251-4087-bc7f-5c9fb4188a2b12014-11-05
51079-241-06EA - Each51079-241405be703-0162-4c44-8117-5b0ed955ef8112014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACAMPROSATE CALCIUMACTIVE INGREDIENT59375N1D0UACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]1
ACAMPROSATEACTIVE MOIETYN4K14YGM3JACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]1
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]1

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 39 · 767 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Smelling SaltsAMMONIAShenzhen Finona Information Technology Co., Ltd3874ec89-0f1d-87b9-e063-6394a90a300a2026-08-24WarningsExact identifier
unii: 5138Q19F1X
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSHodayfa Abu Alkian524e002c-f509-9395-e063-6394a90acd9e2026-08-20WarningsExact identifier
unii: 5138Q19F1X
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSShenzhen Leadtop E-commerce Co.,Ltd.558e8629-6a8d-198d-e063-6294a90ac5fc2026-08-19WarningsExact identifier
unii: 5138Q19F1X
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Smelling SaltAMMONIAShenzhen Jufeng Qisheng Technology Co., Ltd.44e1b2c1-f524-782c-e063-6394a90ad1e42026-08-18WarningsExact identifier
unii: 5138Q19F1X
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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