NDC 0378-4005-01 - Alprazolam

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
0378-4005
Requested NDC
0378-4005-01
Package NDCs from labels
0378-4005-05, 0378-4005-01
Manufacturer
Proficient Rx LP
Effective date
2021-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alprazolam - Proficient Rx LPProficient Rx LP2021-01-01HUMAN PRESCRIPTION DRUG LABEL
Alprazolam - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2020-01-16HUMAN PRESCRIPTION DRUG LABEL
Alprazolam - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2019-03-21HUMAN PRESCRIPTION DRUG LABEL
Alprazolam - Mylan Institutional Inc.Mylan Institutional Inc.2018-11-20HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4005-01EA - Each0378-4005db8fb490-db5b-4dae-b0a6-89478ea866c712012-07-24
0378-4005-05EA - Each0378-40050a7e8ac7-49d3-4c5a-8d4e-6573188690a912012-07-24
0378-4005-77EA - Each0378-40057fbd7360-9bc3-444a-a240-e4090991e3c412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [PROFICIENT RX LP]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALPRAZOLAM TABLET [PROFICIENT RX LP]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [PROFICIENT RX LP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [PROFICIENT RX LP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALPRAZOLAM TABLET [PROFICIENT RX LP]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 3 of 52 · 1,026 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f4671579-aed0-4f93-ab83-248e0d72b5b02026-08-10WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLAldama Pharmaceuticals, Inc492b6d37-47cf-3a28-e063-6294a90a2a182026-08-10WarningsExact identifier
unii: F05Q2T2JA0
Senna SDOCUSATE SODIUM, SENNOSIDESShield Pharmaceuticals Corp0be906d8-3db5-4218-bbdf-f1d1260079902026-08-07WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMP & L Development, LLC4e97dd60-96e3-4b51-b614-c62480af19192026-08-06WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC098d2377-0019-45fe-b995-700b1b1241c42026-08-05WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact identifier
unii: F05Q2T2JA0
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
unii: F05Q2T2JA0
Dual Action Senna Stool SoftenerDOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MGShield Pharmaceuticals Corpa04435df-aace-497f-a3a8-d8e8489db6612026-08-03WarningsExact identifier
unii: F05Q2T2JA0
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
AlprazolamALPRAZOLAMClinical Solutions Wholesale, LLC0cf8b567-201b-44fa-8fd3-c74023aff44f2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YU55MQ3IZY
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMCardinal Health 107, LLCb5e4b14d-bf11-4309-bf6d-65ee9d877a242026-07-28WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
unii: F05Q2T2JA0
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
stool softenerDOCUSATE SODIUMAmazon.com Services LLC4f83953e-3779-43b7-a5c6-7442a0675d9b2026-07-16WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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