FDA.reportPublic FDA data

Famotidine

Product NDC
68071-3201
11-digit product format
680713201
Labeler code
68071
Product ID
68071-3201_1da0eabf-a0b1-c4aa-e063-6394a90ab10e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA078916
Marketing category
ANDA
Marketing start
2016-01-29
Substance
FAMOTIDINE
Active strength
20 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Famotidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui310273

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3201-22024-07-19C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-32024-07-19C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-62024-07-19C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-82024-07-19C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-92024-07-19C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-22023-01-30C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-32023-01-30C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-62023-01-30C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-82023-01-30C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-92023-01-30C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-22021-02-11C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-32021-02-11C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-62021-02-11C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-82021-02-11C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-92021-02-11C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-22021-01-29C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-32021-01-29C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-62021-01-29C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-82021-01-29C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only
68071-3201-92021-01-29C16284748780-1ba0f9c33-4371-a910-e053-dadaa90a0b85Famotidine Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3201-2Famotidine20 in 1 BOTTLETABLET205
68071-3201-3Famotidine30 in 1 BOTTLETABLET305
68071-3201-6Famotidine60 in 1 BOTTLETABLET605
68071-3201-8Famotidine180 in 1 BOTTLETABLET1805
68071-3201-9Famotidine90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3201FAMOTIDINE TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 5 package rows20240720_4b820924-24ad-4a2f-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN4b820924-24ad-4a2f-e054-00144ff88e885
310273famotidine 20 MG Oral TabletSCD4b820924-24ad-4a2f-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3201-26807132010220 TABLET in 1 BOTTLE (68071-3201-2) 20 tablet2017-03-240000-00-00NoNoCurrent
68071-3201-36807132010330 TABLET in 1 BOTTLE (68071-3201-3) 30 tablet2017-03-240000-00-00NoNoCurrent
68071-3201-66807132010660 TABLET in 1 BOTTLE (68071-3201-6) 60 tablet2017-03-240000-00-00NoNoCurrent
68071-3201-868071320108180 TABLET in 1 BOTTLE (68071-3201-8) 180 tablet2017-03-240000-00-00NoNoCurrent
68071-3201-96807132010990 TABLET in 1 BOTTLE (68071-3201-9) 90 tablet2017-03-240000-00-00NoNoCurrent