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 6 of 152 · 3,023 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WISH HAND SANITIZER Banana Cream SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5912d7e8-94a7-e8b9-e063-6394a90a74d62026-08-15WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Caramel Vanilla PopcornALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA591317be-856e-1374-e063-6394a90a7aaf2026-08-15WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Strawberry MuskALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59143edb-41fe-0a1f-e063-6394a90a81a52026-08-15WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST ICED SUGAR COOKIE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedb83a5eef-e2ae-4044-9dce-fd69a5ec5e812026-08-14WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Rose WoodsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58fb4491-2918-c486-e063-6394a90a621f2026-08-14WarningsExact identifier
unii: 3K9958V90M
Alcohol Sanitizer Spray.ETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fb9efe-43f0-1b7f-e063-6394a90a01452026-08-14WarningsExact identifier
unii: 3K9958V90M
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
FRESH FEELS HAND SANITIZER MIST CHILL COCONUT SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited6da508ab-176c-4cca-aa1b-c161d9160cd12026-08-14WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST ICED CHERRY SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedeba7108c-7d96-4393-9444-b3ce2ec7a0602026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BERRY SPRINKLE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited08deb4c2-4ba4-4ec0-b2d2-5cc7f851df4b2026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BERRY SPRINKLE SWIRL SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited424454c9-c1d3-46ec-b186-9159c29f7a4a2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Alcohol SanitizerETHANOLZep Inc.b932a59c-a739-5441-e053-2a95a90a4cfa2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Fuzion Instant Hand SanitizerALCOHOLZep Inc.b43c5701-22ee-1de4-e053-2995a90a8f642026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ee8023-0128-56d6-e053-2a95a90ab4ed2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ed98cd-871b-d862-e053-2995a90a14cc2026-08-13WarningsExact identifier
unii: 3K9958V90M
AFCO 5511 Sanifect E3ETHANOLZep Inc.34795eba-9ec4-6401-e063-6394a90af4282026-08-13WarningsExact identifier
unii: 3K9958V90M
Alcohol Hand SanitizerETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fa90dc-c3b5-787b-e063-6294a90a2e172026-08-13WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Mango Coconut CreamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58faa781-520b-92fa-e063-6294a90a9ecf2026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COCONUT VANILLA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited89dd227a-365f-4d8b-b21a-4f1c1b5c9c0a2026-08-13WarningsExact identifier
unii: 3K9958V90M
SprinJeneALCOHOLHealth and Natural Beauty USA Corp1853f023-f4db-4cd8-a4df-a439bc306cc32026-08-13WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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