FDA.reportPublic FDA data

Famotidine

Product NDC
68001-397
11-digit product format
680010397
Labeler code
68001
Product ID
68001-397_bfda441a-c4ae-7bf3-e053-2a95a90adfe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA206530
Marketing category
ANDA
Marketing start
2019-06-19
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
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
68001-397-00Famotidine100 in 1 BOTTLETABLET, FILM COATED1002
68001-397-08Famotidine1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-397FAMOTIDINE TABLET, FILM COATED [BLUEPOINT LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20210415_8c7ca3cc-ff90-42a7-9218-554cf15348a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNb2e94db0-e737-5ef1-e053-2995a90aaee86
310273famotidine 20 MG Oral TabletSCDb2e94db0-e737-5ef1-e053-2995a90aaee86
310273famotidine 20 MG Oral TabletPSN8c7ca3cc-ff90-42a7-9218-554cf15348a32
284245famotidine 40 MG Oral TabletPSN8c7ca3cc-ff90-42a7-9218-554cf15348a32
310273famotidine 20 MG Oral TabletSCD8c7ca3cc-ff90-42a7-9218-554cf15348a32
284245famotidine 40 MG Oral TabletSCD8c7ca3cc-ff90-42a7-9218-554cf15348a32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-397-0068001039700100 TABLET, FILM COATED in 1 BOTTLE (68001-397-00) 2019-06-190000-00-00NoNoCurrent
68001-397-08680010397081000 TABLET, FILM COATED in 1 BOTTLE (68001-397-08) 2019-06-190000-00-00NoNoCurrent