Ibuprofen and Famotidine

Product NDC: 70748-312
11-digit product format: 707480312
Labeler code: 70748
Product ID: 70748-312_d0532dfa-e690-464f-be38-fce09adce154
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen and Famotidine
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: NDA022519
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2021-09-14
Marketing end: 0000-00-00
Substance: FAMOTIDINE; IBUPROFEN
Active strength: 27 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	70748-312		D	Discontinued by firm		2026-08-17
excluded package	package	70748-312	70748-312-09	D	Discontinued by firm		2026-08-17

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 · 12 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	70748-312-09	`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	70748-312-09	`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	70748-312-09	`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	70748-312-09	`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	70748-312-09	`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	70748-312-09	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022519-001	DUEXIS	FAMOTIDINE; IBUPROFEN	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022519-001	8067451	2026-07-18	U-1196	Drug product	2011-11-30
N022519-001	8309127	2026-07-18		Drug product	2012-11-13
N022519-001	8318202	2026-07-18		Drug product	2012-11-27
N022519-001	8449910	2026-07-18		Drug product	2013-05-28
N022519-001	8501228	2026-07-18	U-1196		2013-08-06

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 2 · 42 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
2026-08-18 06:07:40	2026-07	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022519-001	DUEXIS	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2011-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL		RLD, RS	2011-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL		RLD, RS	2011-04-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL		RLD, RS	2011-04-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL		RLD, RS	2011-04-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL		RLD, RS	2011-04-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL		RLD, RS	2011-04-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL		RLD, RS	2011-04-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL		RLD, RS	2011-04-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL		RLD	2011-04-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022519-001	DUEXIS	26.6MG;800MG	TABLET / ORAL	AB	RLD, RS	2011-04-23	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022519-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022519-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022519-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022519-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022519-001	AB	1	`782e0a99824c…`
2024-02-18 07:12 UTC	2024-02	N022519-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022519-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022519-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022519-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022519-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022519-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022519-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022519-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022519-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022519-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022519-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022519-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022519-001	8067451	2026-07-18	U-1196	Drug product	2011-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022519-001	8309127	2026-07-18		Drug product	2012-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022519-001	8318202	2026-07-18		Drug product	2012-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022519-001	8449910	2026-07-18		Drug product	2013-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022519-001	8501228	2026-07-18	U-1196		2013-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022519-001	8067451	2026-07-18	U-1196	Drug product	2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022519-001	8309127	2026-07-18		Drug product	2012-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022519-001	8318202	2026-07-18		Drug product	2012-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022519-001	8449910	2026-07-18		Drug product	2013-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022519-001	8501228	2026-07-18	U-1196		2013-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022519-001	8067451	2026-07-18	U-1196	Drug product	2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022519-001	8309127	2026-07-18		Drug product	2012-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022519-001	8318202	2026-07-18		Drug product	2012-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022519-001	8449910	2026-07-18		Drug product	2013-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022519-001	8501228	2026-07-18	U-1196		2013-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022519-001	8067451	2026-07-18	U-1196	Drug product	2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022519-001	8309127	2026-07-18		Drug product	2012-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022519-001	8318202	2026-07-18		Drug product	2012-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022519-001	8449910	2026-07-18		Drug product	2013-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022519-001	8501228	2026-07-18	U-1196		2013-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022519-001	8067451	2026-07-18	U-1196	Drug product	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022519-001	8309127	2026-07-18		Drug product	2012-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022519-001	8318202	2026-07-18		Drug product	2012-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022519-001	8449910	2026-07-18		Drug product	2013-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022519-001	8501228	2026-07-18	U-1196		2013-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022519-001	8067451	2026-07-18	U-1196	Drug product	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022519-001	8309127	2026-07-18		Drug product	2012-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022519-001	8318202	2026-07-18		Drug product	2012-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022519-001	8449910	2026-07-18		Drug product	2013-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022519-001	8501228	2026-07-18	U-1196		2013-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022519-001	8067451	2026-07-18	U-1196	Drug product	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022519-001	8309127	2026-07-18		Drug product	2012-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022519-001	8318202	2026-07-18		Drug product	2012-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022519-001	8449910	2026-07-18		Drug product	2013-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022519-001	8501228	2026-07-18	U-1196		2013-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022519-001	8067451	2026-07-18	U-1196	Drug product	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022519-001	8309127	2026-07-18		Drug product	2012-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022519-001	8318202	2026-07-18		Drug product	2012-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022519-001	8449910	2026-07-18		Drug product	2013-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022519-001	8501228	2026-07-18	U-1196		2013-08-06	`2680178bc6a6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70748-312-09	EA - Each	70748-312	779ff88c-6dac-4da7-934a-e093f4ebdabb	1	2021-10-08

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QZO15J2Z8	FAMOTIDINE	76824-35-6	FAMOTIDINE
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70748-312-09	70748031209	90 TABLET, COATED in 1 BOTTLE (70748-312-09)	2021-09-01	0000-00-00	No	No	Current