Kaletra

Product NDC: 21695-362
11-digit product format: 216950362
Labeler code: 21695
Product ID: 21695-362_20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lopinavir and ritonavir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA021906
Marketing category: NDA
Marketing start: 2010-06-18
Marketing end: 0000-00-00
Substance: LOPINAVIR; RITONAVIR
Active strength: 200 mg/1; mg/1
Pharmacologic classes: HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-362		I	Inactivated by FDA		2026-08-10
excluded package	package	21695-362	21695-362-12	I	Inactivated by FDA		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-362-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-362-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-362-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-362-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-362-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-362-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-362-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-362-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-362-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-362-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-362-12	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-362-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-362-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-362-12	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-362-12	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-362-12	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-362-12	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-362-12	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-362-12	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-362-12	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-362-12	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-362-12	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021906-001	KALETRA	LOPINAVIR; RITONAVIR	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28
N021906-002	KALETRA	LOPINAVIR; RITONAVIR	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021906-001	AB
N021906-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL		RLD, RS	2005-10-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL		RLD	2007-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021906-001	KALETRA	200MG;50MG	TABLET / ORAL	AB	RLD, RS	2005-10-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021906-002	KALETRA	100MG;25MG	TABLET / ORAL	AB	RLD	2007-11-09	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021906-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021906-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021906-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021906-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021906-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021906-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021906-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021906-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021906-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021906-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021906-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021906-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021906-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021906-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021906-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021906-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021906-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021906-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021906-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021906-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021906-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021906-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021906-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021906-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021906-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021906-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021906-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021906-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021906-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021906-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021906-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021906-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021906-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021906-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021906-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021906-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021906-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021906-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021906-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021906-002	AB	1	`6a51e52b5d6a…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021906-001	7148359	2019-07-19		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	7148359*PED	2020-01-19		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	7364752	2020-11-10	U-688	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	7364752*PED	2021-05-10		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8268349	2024-08-25		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8399015	2024-08-25		Drug product	2013-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8691878	2024-08-25	U-1513		2014-06-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8309613	2024-12-24	U-688		2012-12-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8268349*PED	2025-02-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8399015*PED	2025-02-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8691878*PED	2025-02-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8309613*PED	2025-06-24		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8470347	2026-09-17		Drug product	2013-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8470347*PED	2027-03-17		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8377952	2027-10-22	U-1372		2013-03-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8025899	2027-12-14		Drug product	2011-10-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8377952*PED	2028-04-22		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-001	8025899*PED	2028-06-14		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	7148359	2019-07-19		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	7148359*PED	2020-01-19		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	7364752	2020-11-10	U-688	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	7364752*PED	2021-05-10		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8268349	2024-08-25		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8399015	2024-08-25		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8691878	2024-08-25	U-1513		2014-06-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8309613	2024-12-24	U-688			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8268349*PED	2025-02-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8399015*PED	2025-02-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8691878*PED	2025-02-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8309613*PED	2025-06-24		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8470347	2026-09-17		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8470347*PED	2027-03-17		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8377952	2027-10-22	U-1372			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8025899	2027-12-14		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8377952*PED	2028-04-22		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021906-002	8025899*PED	2028-06-14		Pediatric extension		`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021906-001	7148359	2019-07-19		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021906-001	7148359*PED	2020-01-19		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021906-001	7364752	2020-11-10	U-688	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021906-001	7364752*PED	2021-05-10		Pediatric extension		`3f01610625f2…`

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-362-12	2019-09-24	C162847	48780-1	934fe258-4c0e-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir and ritonavir) Tablet, Film Coated for Oral use KALETRA (lopinavir and ritonavir) Solution for Oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-362-12	Kaletra	12 in 1 BOTTLE	TABLET, FILM COATED	12		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-362-12	EA - Each	21695-362	0ce04b7f-f139-4c8a-aa1b-acd9c77d0f66	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 [REBEL DISTRIBUTORS CORP]	1
RITONAVIR	ACTIVE INGREDIENT	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LOPINAVIR	ACTIVE MOIETY	2494G1JF75	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
RITONAVIR	ACTIVE MOIETY	O3J8G9O825	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	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 [REBEL DISTRIBUTORS CORP]	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 [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-362	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110104_20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c.zip

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kaletra	LOPINAVIR AND RITONAVIR	AbbVie Inc.	8290add3-4449-4e58-6c97-8fe1eec972e3	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021906 application number: NDA021906

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
847741	Kaletra 200 MG / 50 MG Oral Tablet	PSN	20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c	1
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	PSN	20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c	1
847741	lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra]	SBD	20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c	1
597730	lopinavir 200 MG / ritonavir 50 MG Oral Tablet	SCD	20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c	1
847741	Kaletra 200 MG / 50 MG Oral Tablet	SY	20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-362-12	21695036212	12 in 1 BOTTLE	Historical