FDA.reportPublic FDA data

IBUPROFEN AND FAMOTIDINE

Product NDC
31722-315
11-digit product format
317220315
Labeler code
31722
Product ID
31722-315_097eb368-0559-467f-8a1e-1082e82c15ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen and famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA216814
Marketing category
ANDA
Marketing start
2023-03-15
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
31722-315-90IBUPROFEN AND FAMOTIDINE90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-315-90EA - Each31722-3156d050372-985a-4e4f-a949-06513d7c8b3512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-315IBUPROFEN AND FAMOTIDINE TABLET [CAMBER PHARMACEUTICALS, INC.]4Current NDC, 1 package rows20240809_7dc158a2-fdfa-4a5f-8c28-0ce5650991db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN7dc158a2-fdfa-4a5f-8c28-0ce5650991db4
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD7dc158a2-fdfa-4a5f-8c28-0ce5650991db4
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN16c8b0db-37d0-99d9-e063-6394a90ac31b1
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN3ff33400-30e8-87fa-e063-6394a90a7f5c1
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD16c8b0db-37d0-99d9-e063-6394a90ac31b1
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD3ff33400-30e8-87fa-e063-6394a90a7f5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-315-903172203159090 TABLET in 1 BOTTLE (31722-315-90) 90 tablet2023-03-15NoNoHistorical