FDA.reportPublic FDA data

NDC 61168-101-91 - KYBELLA

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
61168-101
Requested NDC
61168-101-91
Package NDCs from labels
61168-101-01, 61168-101-04, 61168-101-91, 61168-101-94, 61168-101-03
Manufacturer
Kythera Biopharmaceuticals Inc.
Effective date
2026-09-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
KYBELLA - Kythera Biopharmaceuticals Inc.Kythera Biopharmaceuticals Inc.2026-09-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61168-101-01KYBELLA2 mL in 1 VIAL, GLASSINJECTION, SOLUTION225
61168-101-03KYBELLA2 in 1 CARTONINJECTION, SOLUTION225
61168-101-03KYBELLA2 mL in 1 VIAL, GLASSINJECTION, SOLUTION225
61168-101-04KYBELLA4 in 1 CARTONINJECTION, SOLUTION425
61168-101-91KYBELLA2 mL in 1 VIAL, GLASSINJECTION, SOLUTION225
61168-101-94KYBELLA4 in 1 CARTONINJECTION, SOLUTION425

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61168-101KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]24Current NDC, Legacy NDC, 6 package rows20250321_fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61168-101-01ML - Milliliter61168-101aa9b0839-39b8-403c-a243-24eb341f3cf512016-11-08
61168-101-04ML - Milliliter61168-10145fe77b6-e7f4-4c8f-b492-3c4baab536e712016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Deoxycholic AcidACTIVE INGREDIENT005990WHZZKYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]3
Deoxycholic AcidACTIVE MOIETY005990WHZZKYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]3
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHKYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]3
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBKYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]3
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XKYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]3
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IKYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]3
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RKYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]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 31 of 53 · 1,048 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
unii: LKG8494WBH
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d41602-9dcb-eaa8-e063-6394a90a7cfa2024-11-26WarningsExact identifier
unii: 451W47IQ8X
Pure and Gentle LaxativeSODIUM PHOSPHATEMedline Industries, LPe3165538-75dd-4f0f-adc8-d4075de10f1e2024-11-26WarningsExact identifier
unii: GR686LBA74
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d4ddaf-9c07-a7fc-e063-6394a90adc0b2024-11-26WarningsExact identifier
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d5997b-1cae-41c2-e063-6394a90ac74a2024-11-26WarningsExact identifier
unii: 451W47IQ8X
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation37063a49-6b45-4167-875d-49c9dac3f79b2024-11-20WarningsExact identifier
unii: 451W47IQ8X
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMLeosons Overseas Corp90e7c2b4-35e1-4a27-afea-9257c480e1902024-11-19WarningsExact identifier
unii: GR686LBA74
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
unii: LKG8494WBH
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company99a15716-bbb9-4e33-a48d-20c58b81f3922024-11-13Exact identifier
unii: 451W47IQ8X
Itch FormulaANTIPYRINUM, APIS MELLIFICA, CALENDULA OFFICINALIS, CANTHARIS, COPAIVA OFFICINALIS, CROTON TIGLIUM, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, MEZEREUM, NATRUM MURIATICUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, SULPHUR, URTICA URENSDeseret Biologicals, Inc.4dfb177b-bff3-4b6d-8fd9-cadd1df7812c2024-11-12WarningsExact identifier
unii: 451W47IQ8X
Plasma-Lyte 148 (pH 7.4)SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDEBaxter Healthcare Corporationfe935c8d-f42d-42e4-8665-0dc66829f2312024-11-08Exact identifier
unii: 451W47IQ8X
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYd3f90d2f-4536-4d32-800b-7a798f8a35db2024-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.8eb172da-dcd4-4660-4a8f-ad44a14b4af72024-11-06Adverse reactionsExact identifier
unii: 451W47IQ8X
Licefreee EverydaySODIUM CHLORIDETec Laboratories,Inc.407b5fd6-2331-2ba7-e054-00144ff88e882024-11-05WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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