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 9 of 152 · 3,023 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mistify Hand Sanitizer Coconut And Whipped CreamALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5988393d-1554-5588-e063-6394a90a470f2026-08-01WarningsExact identifier
unii: 3K9958V90M
Sherk Hand Sanitizer Green Apple And WatermelonALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd598ec764-bad1-d14b-e063-6394a90a23052026-08-01WarningsExact identifier
unii: 3K9958V90M
Sherk Hand Sanitizer Blue Blueberry And Waffle SyrupALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd598f14fc-c34c-0b4e-e063-6394a90acf0c2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Lavender Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0a6abf-fbab-3db5-e063-6294a90a6a302026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Watermelon Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0ac249-7b91-a83f-e063-6294a90a93742026-08-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY VANILLA SUGAR COOKIES HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0b1e6c-850c-05e0-e063-6294a90afa462026-08-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY SUGAR RUSH HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0ba647-ee25-952a-e063-6294a90ad4712026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify twin cherry hand sanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a148ff2-42bd-7288-e063-6394a90aae642026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Hand Sanitizer StrawberryALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a170880-4867-9aac-e063-6394a90a3e4f2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify strawberry and cream hand sanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a2b3f7b-5981-ed93-e063-6294a90a7b192026-08-01WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Green Certified FoamALCOHOLGOJO Industries, LLC57d91ee6-a166-dc13-e063-6294a90a2f5e2026-07-31WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer GelALCOHOLGOJO Industries, LLC57ecffc4-2c30-84ad-e063-6394a90a68e72026-07-31WarningsExact identifier
unii: 3K9958V90M
Zoono Ultra Hand SanitizerALCOHOLZoono Holdings USA, LLC3dbb255c-1256-66a7-e054-00144ff8d46c2026-07-31WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLAvenacy, LLC90e92d21-9821-4132-b17d-d98d523f12e82026-07-31Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WhiskCare 373ALCOHOLWhisk Products, Inc.cce95a6a-1188-4c69-8f20-4a1670c4c09b2026-07-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 4pk - Fresh Gingerbread/Spiced Cranberry/Vanilla Heaven/Pistachio BruleeALCOHOLShenzhen Lantern Scicence Co.,Ltd.57bd148e-f9eb-dfb6-e063-6394a90a1e122026-07-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 4pk - Fresh Calming Lavender/Sweet Citrus/Coconut Breeze/ Cucumber MelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.57cb54f7-07be-524f-e063-6294a90a2c942026-07-29WarningsExact identifier
unii: 3K9958V90M
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Smart Care Hand Sanitizer with Pouch-Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.57b6f063-9afa-94c9-e063-6394a90a2c352026-07-28WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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