Ibuprofen and famotidine

Product NDC: 69306-266
Requested package NDC: 69306-266-30
11-digit product format: 693060266
Labeler code: 69306
Product ID: 69306-266_e76f4259-9a0c-b18e-e053-2995a90aede8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen and famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Doc Rx
Application: ANDA211890
Marketing category: ANDA
Marketing start: 2021-08-04
Substance: FAMOTIDINE; IBUPROFEN
Active strength: 26.6; 800 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: 2026-12-31
Current FDA listing: Yes

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

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
A211890-001	IBUPROFEN AND FAMOTIDINE	FAMOTIDINE; IBUPROFEN	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211890-001	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.

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	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211890-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211890-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211890-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211890-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211890-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211890-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211890-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211890-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211890-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211890-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211890-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211890-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211890-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211890-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211890-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211890-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211890-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211890-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211890-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211890-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211890-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211890-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211890-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211890-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211890-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211890-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211890-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211890-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211890-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211890-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211890-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211890-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211890-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen and famotidine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	26.6 mg/1
FAMOTIDINE	800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup
5QZO15J2Z8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1100066	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9f5de6af-e555-4efd-a3ed-b72c34c051b6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcae	Product name	7	20260317
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
cf645750-2e70-f6e1-c05a-a52847def5dd	Product name	9	20250312
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
4fdc761c-585e-054b-8ebe-86130a26e4c1	Product name	2	20221205
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69306-266-30	Ibuprofen and famotidine	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69306-266-30	EA - Each	69306-266	1f9dcc45-e69f-4b02-b8dc-233dfc22b751	1	2026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69306-266	IBUPROFEN AND FAMOTIDINE TABLET, FILM COATED [DOC RX]	1	Current NDC, Legacy NDC, 1 package rows	20220901_9f5de6af-e555-4efd-a3ed-b72c34c051b6.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	Ascend Laboratories, LLC	4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	PHOENIX RX LLC	4ee3e849-2197-8883-e063-6394a90a1748	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	REMEDYREPACK INC.	b969bb72-66de-47ce-9d77-64d029e1a5c9	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen Famotidine	IBUPROFEN FAMOTIDINE	Direct_Rx	3f16596d-dd5a-7985-e063-6294a90a6f9d	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	Preferred Pharmaceuticals Inc.	e2f29ca9-9ec8-4b82-8c80-8628d9e3ab2f	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	PHOENIX RX LLC	397f1f23-10c2-569e-e063-6394a90a7164	2025-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	Asclemed USA, Inc.	41123df3-97ac-4c4f-9a89-f76ec03898bb	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	Bryant Ranch Prepack	ee69d3cb-dc95-410c-a7c8-6623073a923d	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	Advanced Rx of Tennessee, LLC	1d625438-34dc-fbba-e063-6294a90afd2f	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	Doc Rx	9f5de6af-e555-4efd-a3ed-b72c34c051b6	2022-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890 ndc (package): 69306-266-30 ndc (product): 69306-266 ndc11 (package): 69306026630

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1100066	ibuprofen 800 MG / famotidine 26.6 MG Oral Tablet	PSN	9f5de6af-e555-4efd-a3ed-b72c34c051b6	1
1100066	famotidine 26.6 MG / ibuprofen 800 MG Oral Tablet	SCD	9f5de6af-e555-4efd-a3ed-b72c34c051b6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69306-266-30	69306026630	30 TABLET, FILM COATED in 1 BOTTLE (69306-266-30)	2022-08-30	0000-00-00	No	No	Current