Ibuprofen and famotidine

Product NDC
67877-626
11-digit product format
678770626
Labeler code
67877
Product ID
67877-626_5107e958-bc99-4832-931e-4c47e25ec6eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen and famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211890-001IBUPROFEN AND FAMOTIDINEFAMOTIDINE; IBUPROFEN26.6MG;800MGTABLET / ORALABRS2021-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211890-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-034b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-03782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2021-08-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211890-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALABRS2021-08-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211890-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211890-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211890-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211890-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211890-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211890-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211890-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211890-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211890-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211890-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211890-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211890-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211890-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211890-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211890-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211890-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211890-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211890-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211890-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211890-001AB1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211890-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211890-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211890-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211890-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211890-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211890-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211890-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211890-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211890-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211890-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211890-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211890-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211890-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211890-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen and famotidine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN26.6 mg/1
FAMOTIDINE800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup
5QZO15J2Z8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-626-01Ibuprofen and famotidine100 in 1 BOTTLETABLET, FILM COATED1008
67877-626-05Ibuprofen and famotidine500 in 1 BOTTLETABLET, FILM COATED5008
67877-626-06Ibuprofen and famotidine1 in 1 BLISTER PACKTABLET, FILM COATED18
67877-626-06Ibuprofen and famotidine6 in 1 CARTONTABLET, FILM COATED68
67877-626-90Ibuprofen and famotidine90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-626-90EA - Each67877-626771e5998-8c9f-49f2-90b2-a3b56f296e7b12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-626IBUPROFEN AND FAMOTIDINE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8Current NDC, Legacy NDC, 5 package rows20240921_4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEDoc Rx9f5de6af-e555-4efd-a3ed-b72c34c051b62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211890
application number: ANDA211890
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAscend Laboratories, LLC4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211890
application number: ANDA211890
ndc (product): 67877-626
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC4ee3e849-2197-8883-e063-6394a90a17482026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211890
application number: ANDA211890
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEREMEDYREPACK INC.b969bb72-66de-47ce-9d77-64d029e1a5c92026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211890
application number: ANDA211890
Ibuprofen FamotidineIBUPROFEN FAMOTIDINEDirect_Rx3f16596d-dd5a-7985-e063-6294a90a6f9d2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211890
application number: ANDA211890
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPreferred Pharmaceuticals Inc.e2f29ca9-9ec8-4b82-8c80-8628d9e3ab2f2025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211890
application number: ANDA211890
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC397f1f23-10c2-569e-e063-6394a90a71642025-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211890
application number: ANDA211890
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAsclemed USA, Inc.41123df3-97ac-4c4f-9a89-f76ec03898bb2025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211890
application number: ANDA211890
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEBryant Ranch Prepackee69d3cb-dc95-410c-a7c8-6623073a923d2024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211890
application number: ANDA211890
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC1d625438-34dc-fbba-e063-6294a90afd2f2024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211890
application number: ANDA211890

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSNee69d3cb-dc95-410c-a7c8-6623073a923d106
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCDee69d3cb-dc95-410c-a7c8-6623073a923d106
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e8
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e8
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN397f1f23-10c2-569e-e063-6394a90a71643
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD397f1f23-10c2-569e-e063-6394a90a71643
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN4ee3e849-2197-8883-e063-6394a90a17481
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSNe2f29ca9-9ec8-4b82-8c80-8628d9e3ab2f1
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSNb969bb72-66de-47ce-9d77-64d029e1a5c91
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN9f5de6af-e555-4efd-a3ed-b72c34c051b61
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN1d625438-34dc-fbba-e063-6294a90afd2f1
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN41123df3-97ac-4c4f-9a89-f76ec03898bb1
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN3f16596d-dd5a-7985-e063-6294a90a6f9d1
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD4ee3e849-2197-8883-e063-6394a90a17481
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD41123df3-97ac-4c4f-9a89-f76ec03898bb1
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD9f5de6af-e555-4efd-a3ed-b72c34c051b61
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCDb969bb72-66de-47ce-9d77-64d029e1a5c91
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD3f16596d-dd5a-7985-e063-6294a90a6f9d1
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCDe2f29ca9-9ec8-4b82-8c80-8628d9e3ab2f1
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD1d625438-34dc-fbba-e063-6294a90afd2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-626-0167877062601100 TABLET, FILM COATED in 1 BOTTLE (67877-626-01) 2021-08-040000-00-00NoNoCurrent
67877-626-0567877062605500 TABLET, FILM COATED in 1 BOTTLE (67877-626-05) 2021-08-040000-00-00NoNoCurrent
67877-626-06678770626066 BLISTER PACK in 1 CARTON (67877-626-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2021-08-040000-00-00NoNoCurrent
67877-626-906787706269090 TABLET, FILM COATED in 1 BOTTLE (67877-626-90) 2021-08-040000-00-00NoNoCurrent