FDA.reportPublic FDA data

Famotidine

Product NDC
65862-860
11-digit product format
658620860
Labeler code
65862
Product ID
65862-860_e0c726f6-8257-4dba-b2f9-d78d28097bd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206530
Marketing category
ANDA
Marketing start
2015-12-22
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
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
FAMOTIDINE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui284245, 310273

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
65862-860-01Famotidine100 in 1 BOTTLETABLET, FILM COATED10010
65862-860-05Famotidine500 in 1 BOTTLETABLET, FILM COATED50010
65862-860-10Famotidine10 in 1 BLISTER PACKTABLET, FILM COATED1010
65862-860-30Famotidine30 in 1 BOTTLETABLET, FILM COATED3010
65862-860-78Famotidine10 in 1 CARTONTABLET, FILM COATED1010
65862-860-99Famotidine1000 in 1 BOTTLETABLET, FILM COATED100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-860-01EA - Each65862-860a1fe089f-a6f4-45ff-8cc4-42830de4326912016-05-16
65862-860-99EA - Each65862-860b62bffaf-541c-4ca0-803f-368096bd435712017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-860FAMOTIDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]10Current NDC, Legacy NDC, 6 package rows20250308_b0798337-1a73-415e-8416-613984ce5c65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNb0798337-1a73-415e-8416-613984ce5c6510
284245famotidine 40 MG Oral TabletPSNb0798337-1a73-415e-8416-613984ce5c6510
310273famotidine 20 MG Oral TabletSCDb0798337-1a73-415e-8416-613984ce5c6510
284245famotidine 40 MG Oral TabletSCDb0798337-1a73-415e-8416-613984ce5c6510
284245famotidine 40 MG Oral TabletPSNba35f425-9321-4fd8-91d4-053a1edb3a055
284245famotidine 40 MG Oral TabletSCDba35f425-9321-4fd8-91d4-053a1edb3a055
284245famotidine 40 MG Oral TabletPSNf32d0929-de22-4bec-9e24-bb549cf2679f2
284245famotidine 40 MG Oral TabletSCDf32d0929-de22-4bec-9e24-bb549cf2679f2
284245famotidine 40 MG Oral TabletPSNd8cfa644-7cad-41b9-82a0-242a783fcbc81
284245famotidine 40 MG Oral TabletSCDd8cfa644-7cad-41b9-82a0-242a783fcbc81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-860-0165862086001100 TABLET, FILM COATED in 1 BOTTLE (65862-860-01) 2015-12-220000-00-00NoNoCurrent
65862-860-0565862086005500 TABLET, FILM COATED in 1 BOTTLE (65862-860-05) 2015-12-220000-00-00NoNoCurrent
65862-860-106586208601010 in 1 BLISTER PACKHistorical
65862-860-306586208603030 TABLET, FILM COATED in 1 BOTTLE (65862-860-30) 2015-12-220000-00-00NoNoCurrent
65862-860-49658620860494000 TABLET, FILM COATED in 1 BAG (65862-860-49)22-DEC-15Current
65862-860-606586208606060000 TABLET, FILM COATED in 1 BAG (65862-860-60)11-MAY-19Current
65862-860-786586208607810 BLISTER PACK in 1 CARTON (65862-860-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-860-10) 10 blister pack2015-12-220000-00-00NoNoCurrent
65862-860-99658620860991000 TABLET, FILM COATED in 1 BOTTLE (65862-860-99) 2015-12-220000-00-00NoNoCurrent