Kaletra

Product NDC: 70518-0091
11-digit product format: 705180091
Labeler code: 70518
Product ID: 70518-0091_d2a9d223-db43-7ada-e053-2995a90a7dea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lopinavir and Ritonavir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA021906
Marketing category: NDA
Marketing start: 2016-12-29
Marketing end: 0000-00-00
Substance: LOPINAVIR; RITONAVIR
Active strength: 200 mg/1; mg/1
Pharmacologic classes: HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],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]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-0091		D	Discontinued by firm	2026-08-10
excluded package	package	70518-0091	70518-0091-0	D	Discontinued by firm	2026-08-10
excluded package	package	70518-0091	70518-0091-1	D	Discontinued by firm	2026-08-10
excluded package	package	70518-0091	70518-0091-2	D	Discontinued by firm	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 · 54 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0091-0	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0091-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0091-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0091-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0091-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0091-0	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-0091-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-0091-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-0091-0	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-0091-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-0091-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-0091-0	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-0091-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-0091-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-0091-0	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-0091-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-0091-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-0091-0	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-0091-2	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-0091-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-0091-0	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-0091-2	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-0091-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-0091-0	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-0091-2	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-0091-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-0091-0	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0091-2	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0091-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0091-0	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-0091-2	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-0091-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-0091-0	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-0091-2	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-0091-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-0091-0	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70518-0091-2	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70518-0091-2	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70518-0091-2	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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, Related label table
NDC	Effective	Related label
70518-0091-0	2025-11-05	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, for oral use KALETRA (lopinavir and ritonavir) oral solution Initial U.S. Approval: 2000
70518-0091-1	2025-11-05	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, for oral use KALETRA (lopinavir and ritonavir) oral solution Initial U.S. Approval: 2000
70518-0091-2	2025-11-05	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, for oral use KALETRA (lopinavir and ritonavir) oral solution Initial U.S. Approval: 2000
70518-0091-0	2023-01-30	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, for oral use KALETRA (lopinavir and ritonavir) oral solution Initial U.S. Approval: 2000
70518-0091-1	2023-01-30	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, for oral use KALETRA (lopinavir and ritonavir) oral solution Initial U.S. Approval: 2000
70518-0091-2	2023-01-30	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, for oral use KALETRA (lopinavir and ritonavir) oral solution Initial U.S. Approval: 2000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-0091	KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REMEDYREPACK INC.]	10	Legacy NDC	20211210_f34556f4-b4a7-4b2e-9096-5c4557333271.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0091-2	70518009102	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0091-2)	2017-02-28	0000-00-00	No	No	Current