FDA.reportPublic FDA data

NDC 0051-8450-01 - Androgel

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
0051-8450
Requested NDC
0051-8450-01
Package NDCs from labels
0051-8450-01, 0051-8450-30
Manufacturer
AbbVie Inc.
Effective date
2019-05-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Androgel - AbbVie Inc.AbbVie Inc.2019-05-01HUMAN PRESCRIPTION DRUG LABEL
Androgel - Physicians Total Care, Inc.Physicians Total Care, Inc.2011-12-15HUMAN PRESCRIPTION DRUG LABEL
AndrogelRebel Distributors Corp.2010-09-08HUMAN 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
0051-8450-01GM - Gram0051-84506b1fc40b-c55d-4f7c-a12e-6235e16530b512012-07-24
0051-8450-30GM - Gram0051-8450808604ec-7aa4-4ea6-b767-29dd9feaf43812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
testosteroneACTIVE INGREDIENT3XMK78S47OANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]78
testosteroneACTIVE MOIETY3XMK78S47OANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]78
alcoholINACTIVE INGREDIENT3K9958V90MANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]78
carbomer homopolymer type CINACTIVE INGREDIENT4Q93RCW27EANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]78
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]78
sodium hydroxideINACTIVE INGREDIENT55X04QC32IANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]78
waterINACTIVE INGREDIENT059QF0KO0RANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]78
testosteroneACTIVE INGREDIENT3XMK78S47OANDROGEL (TESTOSTERONE) GEL [PHYSICIANS TOTAL CARE, INC.]3
testosteroneACTIVE MOIETY3XMK78S47OANDROGEL (TESTOSTERONE) GEL [PHYSICIANS TOTAL CARE, INC.]3
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1
TESTOSTERONEACTIVE MOIETY3XMK78S47OANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]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 5 of 152 · 3,023 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand sanitizer disinfectionHAND SANITIZER DISINFECTIONGuangzhou Huanmei Cosmetics Co., Ltd.598bf234-d2da-4e59-e063-6294a90a67e42026-08-21WarningsExact identifier
unii: 3K9958V90M
hand sanitizer- light yellow 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598bf8cd-2a79-8b56-e063-6394a90a42a82026-08-21WarningsExact identifier
unii: 3K9958V90M
hand sanitizer- light pink 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598c41f0-908d-df52-e063-6394a90a3c8d2026-08-21WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer CARAMEL DREAM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOef6fa913-b65d-4b3a-b88a-89cdbbf740492026-08-21WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer FRESH GUAVA SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOee59fcad-e88b-4fc0-b71c-724881400a792026-08-21WarningsExact identifier
unii: 3K9958V90M
hand sanitizer strawberry matcha scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO42fdd67d-e77c-4d08-9676-f37ec43f7e432026-08-21WarningsExact identifier
unii: 3K9958V90M
WISH ADVANCED HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f9f2a-7857-0752-e063-6394a90af8de2026-08-19WarningsExact identifier
unii: 3K9958V90M
WISH ADVANCED HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595fd84a-fead-3818-e063-6394a90aa4f12026-08-19WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER vanilla creamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594bb903-2406-abb9-e063-6294a90a1cee2026-08-18WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER rose petalALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594befe7-1701-02a2-e063-6294a90a236c2026-08-18WarningsExact identifier
unii: 3K9958V90M
WISH ADVANCED HAND SANITIZER SWEETR GUAVA FRESH COCONUTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594c32b7-6905-4ab9-e063-6294a90a1db32026-08-18WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLLidl US, LLCc7746330-2943-491a-bafc-0c8dd4fa40e22026-08-18Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLNice-Pak Products, LLCdc071394-60de-4b13-a962-9a643b01b1062026-08-18Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
HDXETHYL ALCOHOLApollo Health and Beauty Caredf0063b2-2e30-428e-b5cf-24e566c388c22026-08-18WarningsExact identifier
unii: 3K9958V90M
WISH ADVANCED HAND SANITIZER BLACK PLUM VANILLAALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f0c9f-645d-a047-e063-6294a90a996a2026-08-18WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER cherry rougeALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593a7fc9-8d56-f9cb-e063-6294a90a3dae2026-08-17WarningsExact identifier
unii: 3K9958V90M
Ethyl alcohol 62%ETHYL ALCOHOL 62%UpLift Brands LLC5941ee9e-d109-b2be-e063-6394a90aa3232026-08-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Sea Salt Green HerbsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59259ea7-f1bb-9688-e063-6394a90afb3c2026-08-16WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Marshmallow VanillaALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5925e9a7-eb93-c0e3-e063-6294a90ad2652026-08-16WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Lychee Vanilla MilkALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA592625c8-cbc5-f864-e063-6394a90aeb9d2026-08-16WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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