FDA.reportPublic FDA data

NDC 50268-069-11 - Amantadine HCl

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
50268-069
Requested NDC
50268-069-11
Package NDCs from labels
50268-069-11, 50268-069-15
Manufacturer
AvPAK
Effective date
2025-06-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amantadine HCl - AvPAKAvPAK2025-06-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-069-11Amantadine HCl1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED110
50268-069-15Amantadine HCl50 in 1 BOX, UNIT-DOSECAPSULE, LIQUID FILLED5010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-069AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]9Current NDC, Legacy NDC, 2 package rows20220118_461e6444-189e-62ed-6c61-1c36a04459c6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-069-11EA - Each50268-0692b4adee1-8649-4f8d-bc86-c7d649088cb612015-04-03
50268-069-15EA - Each50268-0693827b1df-315b-4d6d-92d0-071ab8a35c3512014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMANTADINE HYDROCHLORIDEACTIVE INGREDIENTM6Q1EO9TD0AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]3
AMANTADINEACTIVE MOIETYBF4C9Z1J53AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]3
GELATININACTIVE INGREDIENT2G86QN327LAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]3
SORBITANINACTIVE INGREDIENT6O92ICV9RUAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]3
SORBITOLINACTIVE INGREDIENT506T60A25RAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]3
SOYBEAN OILINACTIVE INGREDIENT241ATL177AAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]3
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK]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 183 · 3,660 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
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Pepto Gas plus BloatingSIMETHICONEThe Procter & Gamble Manufacturing Company3d80a5bb-0ed0-769a-e063-6394a90ac50c2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Gas Relief Mint FlavorSIMETHICONERaritan Pharmaceuticals Inc329388cb-3ca1-4ecb-8b50-b1f9e00525592026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
SimethiconeSIMETHICONESOFTGEL HEALTHCARE PRIVATE LIMITED3205339a-3914-4e25-e063-6394a90a07cd2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Simethicone 125MG Gas ReliefSIMETHICONE 125 MGOne2Zee Limited Liability Company0df348bf-5a07-4f36-ae70-ca2961a9ce7e2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
Infants Gas Relief DropsSIMETHICONEDOLGENCORP INC6b132ac0-e8eb-4199-85ad-5976558ee9c82026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone DropsSIMETHICONE DROPSEverpharm LLC5a6d2c1f-4067-969f-e063-6394a90aa83f2026-09-02WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEAkron Pharmadcdd0daf-5ef0-4cb2-872d-89ed6e9f6d602026-09-01WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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