Kaletra

Product NDC: 0074-6799
11-digit product format: 000746799
Labeler code: 0074
Product ID: 0074-6799_a0e519cd-694a-44de-9a89-eac59fce76c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lopinavir and Ritonavir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AbbVie Inc.
Application: NDA021906
Marketing category: NDA
Marketing start: 2010-06-18
Substance: LOPINAVIR; RITONAVIR
Active strength: 200; 50 mg/1; mg/1
Pharmacologic classes: Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Kaletra
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOPINAVIR	200 mg/1
RITONAVIR	50 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	O3J8G9O825, 2494G1JF75
Rxcui	311369, 597730, 746645, 847741, 847745, 847749

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1d2364f5-8b1e-7c9a-4518-7b359d95fa50	Product name	2	20250116
00d976a9-a12a-db3d-ac4e-27498af714cf	Product name	5	20250115
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
7a5f5ac7-15c0-4d8b-bea4-b3b28cb83a8d	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
c8f34825-48cd-e7db-4048-c3be840a9308	Product name	5	20230123
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d1ee4fdb-1116-417b-8889-dc05571445b3	Product name	1	20160825
f8d26468-b1dc-49d8-a188-8b5d531405ef	Product name	1	20150731
0b1bb9d1-e628-4e7c-aada-fd6532257932	Product name	1	20150416
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
96979b26-bb9a-43d8-e3a6-d69b9e9f75e5	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0074-6799-22	Kaletra	120 in 1 BOTTLE	TABLET, FILM COATED	120		1700
0074-6799-30	Kaletra	120 in 1 BOTTLE	TABLET, FILM COATED	120		1700

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0074-6799-22	EA - Each	0074-6799	ded85eab-201c-4240-92fc-4245ba12e006	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOPINAVIR	ACTIVE INGREDIENT	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
RITONAVIR	ACTIVE INGREDIENT	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
LOPINAVIR	ACTIVE MOIETY	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
RITONAVIR	ACTIVE MOIETY	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
AMMONIUM GLYCYRRHIZATE	INACTIVE INGREDIENT	3VRD35U26C	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
MENTHOL, UNSPECIFIED FORM	INACTIVE INGREDIENT	L7T10EIP3A	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
SODIUM CITRATE, UNSPECIFIED FORM	INACTIVE INGREDIENT	1Q73Q2JULR	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
VANILLA	INACTIVE INGREDIENT	Q74T35078H	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
WATER	INACTIVE INGREDIENT	059QF0KO0R	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1567
LOPINAVIR	ACTIVE INGREDIENT	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
RITONAVIR	ACTIVE INGREDIENT	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
LOPINAVIR	ACTIVE MOIETY	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
RITONAVIR	ACTIVE MOIETY	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
LOPINAVIR	ACTIVE INGREDIENT	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
LOPINAVIR	ACTIVE INGREDIENT	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
Lopinavir	ACTIVE INGREDIENT	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
LOPINAVIR	ACTIVE INGREDIENT	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LOPINAVIR	ACTIVE INGREDIENT	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
RITONAVIR	ACTIVE INGREDIENT	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
RITONAVIR	ACTIVE INGREDIENT	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
Ritonavir	ACTIVE INGREDIENT	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
RITONAVIR	ACTIVE INGREDIENT	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
RITONAVIR	ACTIVE INGREDIENT	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
LOPINAVIR	ACTIVE MOIETY	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
LOPINAVIR	ACTIVE MOIETY	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
Lopinavir	ACTIVE MOIETY	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
LOPINAVIR	ACTIVE MOIETY	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LOPINAVIR	ACTIVE MOIETY	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
RITONAVIR	ACTIVE MOIETY	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
RITONAVIR	ACTIVE MOIETY	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
Ritonavir	ACTIVE MOIETY	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
RITONAVIR	ACTIVE MOIETY	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
RITONAVIR	ACTIVE MOIETY	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0074-6799	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]	1700	Current NDC, Legacy NDC, 2 package rows	20240922_8290add3-4449-4e58-6c97-8fe1eec972e3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2494G1JF75	LOPINAVIR	192725-17-0	LOPINAVIR
O3J8G9O825	RITONAVIR	155213-67-5	RITONAVIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
847745	Kaletra 100 MG/ 25 MG Oral Tablet	PSN	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
847741	Kaletra 200 MG / 50 MG Oral Tablet	PSN	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
847749	Kaletra 80 MG / 20 MG in 1 mL Oral Solution	PSN	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
746645	lopinavir 100 MG / ritonavir 25 MG Oral Tablet	PSN	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	PSN	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
311369	lopinavir 80 MG / ritonavir 20 MG in 1 mL Oral Solution	PSN	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
847745	lopinavir 100 MG / ritonavir 25 MG Oral Tablet [Kaletra]	SBD	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
847741	lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra]	SBD	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
847749	lopinavir 80 MG/ML / ritonavir 20 MG/ML Oral Solution [Kaletra]	SBD	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
746645	lopinavir 100 MG / ritonavir 25 MG Oral Tablet	SCD	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	SCD	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
311369	lopinavir 80 MG/ML / ritonavir 20 MG/ML Oral Solution	SCD	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
847745	Kaletra 100 MG / 25 MG Oral Tablet	SY	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
847741	Kaletra 200 MG / 50 MG Oral Tablet	SY	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
847749	Kaletra 80 MG / 20 MG per 1 ML Oral Solution	SY	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
311369	lopinavir 400 MG / ritonavir 100 MG per 5 ML Oral Solution	SY	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
311369	lopinavir 80 MG / ritonavir 20 MG per 1 ML Oral Solution	SY	8290add3-4449-4e58-6c97-8fe1eec972e3	1700
847741	Kaletra 200 MG / 50 MG Oral Tablet	PSN	c7fc2d1e-802e-4da1-9763-3355f8aafe3a	3
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	PSN	c7fc2d1e-802e-4da1-9763-3355f8aafe3a	3
847741	lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra]	SBD	c7fc2d1e-802e-4da1-9763-3355f8aafe3a	3
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	SCD	c7fc2d1e-802e-4da1-9763-3355f8aafe3a	3
847741	Kaletra 200 MG / 50 MG Oral Tablet	SY	c7fc2d1e-802e-4da1-9763-3355f8aafe3a	3
847741	Kaletra 200 MG / 50 MG Oral Tablet	PSN	bb144a40-46db-4c61-e053-2995a90a1206	2
847741	Kaletra 200 MG / 50 MG Oral Tablet	PSN	47fdef53-4060-4372-9b48-fdb39a7e3fd3	2
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	PSN	47fdef53-4060-4372-9b48-fdb39a7e3fd3	2
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	PSN	bb144a40-46db-4c61-e053-2995a90a1206	2
847741	lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra]	SBD	bb144a40-46db-4c61-e053-2995a90a1206	2
847741	lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra]	SBD	47fdef53-4060-4372-9b48-fdb39a7e3fd3	2
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	SCD	47fdef53-4060-4372-9b48-fdb39a7e3fd3	2
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	SCD	bb144a40-46db-4c61-e053-2995a90a1206	2
847741	Kaletra 200 MG / 50 MG Oral Tablet	SY	47fdef53-4060-4372-9b48-fdb39a7e3fd3	2
847741	Kaletra 200 MG / 50 MG Oral Tablet	SY	bb144a40-46db-4c61-e053-2995a90a1206	2
847741	Kaletra 200 MG / 50 MG Oral Tablet	PSN	3fa34341-1dce-4bad-b97e-f466e96a0bbe	1
847741	Kaletra 200 MG / 50 MG Oral Tablet	PSN	20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c	1
847741	Kaletra 200 MG / 50 MG Oral Tablet	PSN	dac2ea61-f5ce-45b8-b4aa-d761c5aecd74	1
847741	Kaletra 200 MG / 50 MG Oral Tablet	PSN	0b126fcd-2385-409f-9269-5bf886649c1a	1
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	PSN	3fa34341-1dce-4bad-b97e-f466e96a0bbe	1
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	PSN	20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c	1
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	PSN	dac2ea61-f5ce-45b8-b4aa-d761c5aecd74	1
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	PSN	0b126fcd-2385-409f-9269-5bf886649c1a	1
847741	lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra]	SBD	dac2ea61-f5ce-45b8-b4aa-d761c5aecd74	1
847741	lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra]	SBD	3fa34341-1dce-4bad-b97e-f466e96a0bbe	1
847741	lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra]	SBD	20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c	1
847741	lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra]	SBD	0b126fcd-2385-409f-9269-5bf886649c1a	1
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	SCD	3fa34341-1dce-4bad-b97e-f466e96a0bbe	1
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	SCD	20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c	1
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	SCD	dac2ea61-f5ce-45b8-b4aa-d761c5aecd74	1
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	SCD	0b126fcd-2385-409f-9269-5bf886649c1a	1
847741	Kaletra 200 MG / 50 MG Oral Tablet	SY	3fa34341-1dce-4bad-b97e-f466e96a0bbe	1
847741	Kaletra 200 MG / 50 MG Oral Tablet	SY	20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c	1
847741	Kaletra 200 MG / 50 MG Oral Tablet	SY	dac2ea61-f5ce-45b8-b4aa-d761c5aecd74	1
847741	Kaletra 200 MG / 50 MG Oral Tablet	SY	0b126fcd-2385-409f-9269-5bf886649c1a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0074-6799-22	00074679922	120 TABLET, FILM COATED in 1 BOTTLE (0074-6799-22)	2010-06-18	0000-00-00	No	No	Current
0074-6799-30	00074679930	120 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Kaletra	NuCare Pharmaceuticals,Inc.	2023-07-06	HUMAN PRESCRIPTION DRUG LABEL	2
Kaletra	AbbVie Inc.	2023-04-01	HUMAN PRESCRIPTION DRUG LABEL	1700
Kaletra	REMEDYREPACK INC.	2021-12-08	HUMAN PRESCRIPTION DRUG LABEL	10
Kaletra	DOH CENTRAL PHARMACY	2017-02-03	HUMAN PRESCRIPTION DRUG LABEL	3
Kaletra	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-10-10	HUMAN PRESCRIPTION DRUG LABEL	1
Kaletra	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-10-10	HUMAN PRESCRIPTION DRUG LABEL	1
Kaletra	Physicians Total Care, Inc.	2012-04-06	HUMAN PRESCRIPTION DRUG LABEL	2
Kaletra	HHS/Program Support Center/Supply Service Center \| HHS Supply Service Center - Perry Point, MD 21902	2012-03-06	HUMAN PRESCRIPTION DRUG LABEL	1
Kaletra	Rebel Distributors Corp	2010-12-28	HUMAN PRESCRIPTION DRUG LABEL	1

Kaletra

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#