FDA.reportPublic FDA data

NDC 68084-603-11 - Nifedipine

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
68084-603
Requested NDC
68084-603-11
Package NDCs from labels
68084-603-11, 68084-603-21, 68084-603-65
Manufacturer
American Health Packaging
Effective date
2025-05-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nifedipine - American Health PackagingAmerican Health Packaging2025-05-16HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-603-11Nifedipine1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE110
68084-603-21Nifedipine30 in 1 BOX, UNIT-DOSETABLET, FILM COATED, EXTENDED RE3010
68084-603-65Nifedipine50 in 1 CARTONTABLET, FILM COATED, EXTENDED RE5010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-603NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 3 package rows20250522_b11026f8-dea0-49ac-8725-0ef7dc27923f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-603-11EA - Each68084-603d8556926-7c55-4eb4-bcd2-96cc727d6ef512012-07-24
68084-603-21EA - Each68084-6035ea836b5-5719-464d-9074-f7ea335c357212012-07-24
68084-603-65EA - Each68084-603032597bd-ff9f-4931-9061-7d3bd6c5c09a12023-03-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
TRIACETININACTIVE INGREDIENTXHX3C3X673NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2

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 187 · 3,723 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
unii: 451W47IQ8X
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
unii: 451W47IQ8X
Adrenal SupportADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUMNaturalCare31a5d522-15cd-432a-bf87-f721bcbe2e312026-09-02WarningsExact identifier
unii: 451W47IQ8X
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 451W47IQ8X
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsExact identifier
unii: 451W47IQ8X
BMNP Nat MurNATRUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a57ccfd-ab6f-cb2c-e063-6394a90ae9e62026-08-31WarningsExact identifier
unii: 451W47IQ8X
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: 451W47IQ8X
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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