FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE26.6 mg/1
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8, WK2XYI10QM
Rxcui1100066

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

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