FDA.reportPublic FDA data

Famotidine

Product NDC
71335-0231
11-digit product format
713350231
Labeler code
71335
Product ID
71335-0231_f1a373ef-7240-45b4-80ff-066a9d0ebb53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078916
Marketing category
ANDA
Marketing start
2016-01-29
Substance
FAMOTIDINE
Active strength
40 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Famotidine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui284245

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0231-1Famotidine30 in 1 BOTTLETABLET3010
71335-0231-2Famotidine60 in 1 BOTTLETABLET6010
71335-0231-3Famotidine100 in 1 BOTTLETABLET10010
71335-0231-4Famotidine90 in 1 BOTTLETABLET9010
71335-0231-5Famotidine15 in 1 BOTTLETABLET1510
71335-0231-6Famotidine120 in 1 BOTTLETABLET12010
71335-0231-7Famotidine20 in 1 BOTTLETABLET2010
71335-0231-8Famotidine10 in 1 BOTTLETABLET1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0231-1EA - Each71335-0231f244d56e-970c-4550-84de-b2fc495b979312018-01-12
71335-0231-2EA - Each71335-02314e8ba45d-8c06-4124-a085-b76ec10ed3ef12018-01-12
71335-0231-3EA - Each71335-0231b57752df-9ecc-41eb-8ef8-df3fc5fe5a5012018-01-12
71335-0231-4EA - Each71335-02312e23d151-55f0-4198-973e-a9eafcba28db12018-01-12
71335-0231-5EA - Each71335-0231d5e8ae38-9768-411d-bf46-36dffcc842c012018-01-12
71335-0231-6EA - Each71335-02311b931ee3-4820-4c5d-adab-fcce72b58f6d12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0231FAMOTIDINE TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 8 package rows20231201_db3af7cc-efc6-4934-acff-8bb2d31fe829.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSNdb3af7cc-efc6-4934-acff-8bb2d31fe82910
284245famotidine 40 MG Oral TabletSCDdb3af7cc-efc6-4934-acff-8bb2d31fe82910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0231-17133502310130 TABLET in 1 BOTTLE (71335-0231-1) 30 tablet2018-07-260000-00-00NoNoCurrent
71335-0231-27133502310260 TABLET in 1 BOTTLE (71335-0231-2) 60 tablet2018-03-060000-00-00NoNoCurrent
71335-0231-371335023103100 TABLET in 1 BOTTLE (71335-0231-3) 100 tablet2019-11-110000-00-00NoNoCurrent
71335-0231-47133502310490 TABLET in 1 BOTTLE (71335-0231-4) 90 tablet2018-07-160000-00-00NoNoCurrent
71335-0231-57133502310515 TABLET in 1 BOTTLE (71335-0231-5) 15 tablet2019-01-310000-00-00NoNoCurrent
71335-0231-671335023106120 TABLET in 1 BOTTLE (71335-0231-6) 120 tablet2021-12-270000-00-00NoNoCurrent
71335-0231-77133502310720 TABLET in 1 BOTTLE (71335-0231-7) 20 tablet2021-12-270000-00-00NoNoCurrent
71335-0231-87133502310810 TABLET in 1 BOTTLE (71335-0231-8) 10 tablet2021-12-27NoNoHistorical