FDA.reportPublic FDA data

Famotidine

Product NDC
71335-1950
11-digit product format
713351950
Labeler code
71335
Product ID
71335-1950_6e3954f4-f887-4ead-9790-c5262ccf5307
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075718
Marketing category
ANDA
Marketing start
2001-04-16
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
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
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
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1950-0Famotidine40 in 1 BOTTLETABLET, FILM COATED40102
71335-1950-1Famotidine30 in 1 BOTTLETABLET, FILM COATED30102
71335-1950-2Famotidine60 in 1 BOTTLETABLET, FILM COATED60102
71335-1950-3Famotidine20 in 1 BOTTLETABLET, FILM COATED20102
71335-1950-4Famotidine90 in 1 BOTTLETABLET, FILM COATED90102
71335-1950-5Famotidine100 in 1 BOTTLETABLET, FILM COATED100102
71335-1950-6Famotidine10 in 1 BOTTLETABLET, FILM COATED10102
71335-1950-7Famotidine120 in 1 BOTTLETABLET, FILM COATED120102
71335-1950-8Famotidine50 in 1 BOTTLETABLET, FILM COATED50102
71335-1950-9Famotidine14 in 1 BOTTLETABLET, FILM COATED14102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1950-0EA - Each71335-19506663d7de-f462-48b5-8038-bfe0b17b2c6512026-04-20
71335-1950-1EA - Each71335-1950fe791c10-7c08-45a3-a0f8-ba1cc4872ca012026-04-20
71335-1950-2EA - Each71335-1950a7c01c76-8c97-4ab3-bcb1-c41195699c5412026-04-20
71335-1950-3EA - Each71335-1950b655b373-4f12-45ec-81e5-0ad3b44e399812026-04-20
71335-1950-4EA - Each71335-195037f963f6-cc39-4bfd-ac17-cebc4b45ab8012026-04-20
71335-1950-5EA - Each71335-1950fa48d20a-79ae-4f1e-90b3-38e9194a662112026-04-20
71335-1950-6EA - Each71335-195009044c4f-2267-4f37-86c2-6046e7afa71012026-04-20
71335-1950-7EA - Each71335-1950772b8031-f4ad-46f2-9110-432c70a040cd12026-04-20
71335-1950-8EA - Each71335-1950cb23ba6f-ffee-4ddb-87c2-3433d1d1bc4c12026-04-20
71335-1950-9EA - Each71335-1950851a2b6e-ba70-4784-a6a5-e22907b08ec812026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1950FAMOTIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 10 package rows20231201_545d5c1f-ec1c-4135-965f-333ad888d96f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN545d5c1f-ec1c-4135-965f-333ad888d96f102
310273famotidine 20 MG Oral TabletSCD545d5c1f-ec1c-4135-965f-333ad888d96f102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1950-07133519500040 TABLET, FILM COATED in 1 BOTTLE (71335-1950-0) 2026-03-31NoNoHistorical
71335-1950-17133519500130 TABLET, FILM COATED in 1 BOTTLE (71335-1950-1) 2026-03-310000-00-00NoNoCurrent
71335-1950-27133519500260 TABLET, FILM COATED in 1 BOTTLE (71335-1950-2) 2026-03-310000-00-00NoNoCurrent
71335-1950-37133519500320 TABLET, FILM COATED in 1 BOTTLE (71335-1950-3) 2026-03-310000-00-00NoNoCurrent
71335-1950-47133519500490 TABLET, FILM COATED in 1 BOTTLE (71335-1950-4) 2026-03-310000-00-00NoNoCurrent
71335-1950-571335195005100 TABLET, FILM COATED in 1 BOTTLE (71335-1950-5) 2026-03-310000-00-00NoNoCurrent
71335-1950-67133519500610 TABLET, FILM COATED in 1 BOTTLE (71335-1950-6) 2026-03-310000-00-00NoNoCurrent
71335-1950-771335195007120 TABLET, FILM COATED in 1 BOTTLE (71335-1950-7) 2026-03-310000-00-00NoNoCurrent
71335-1950-87133519500850 TABLET, FILM COATED in 1 BOTTLE (71335-1950-8) 2026-03-310000-00-00NoNoCurrent
71335-1950-97133519500914 TABLET, FILM COATED in 1 BOTTLE (71335-1950-9) 2026-03-31NoNoHistorical