FDA.reportPublic FDA data

Famotidine

Product NDC
68001-494
11-digit product format
680010494
Labeler code
68001
Product ID
68001-494_f79353ac-03fd-35b1-e053-6394a90a86ae
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA206531
Marketing category
ANDA
Marketing start
2021-04-07
Substance
FAMOTIDINE
Active strength
10 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
FAMOTIDINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui199047

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
68001-494-04Famotidine1 in 1 CARTONTABLET13
68001-494-04Famotidine30 in 1 BOTTLETABLET303
68001-494-06Famotidine60 in 1 BOTTLETABLET603
68001-494-06Famotidine1 in 1 CARTONTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-494-04EA - Each68001-494ca1a15a1-0258-4b20-af07-64d6f96ac44812021-06-02
68001-494-06EA - Each68001-494210ac992-220c-455c-925d-295442c0a2fa12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-494FAMOTIDINE TABLET [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 4 package rows20230324_befd8d44-c6f7-eca2-e053-2995a90a714b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSNbefd8d44-c6f7-eca2-e053-2995a90a714b3
199047famotidine 10 MG Oral TabletSCDbefd8d44-c6f7-eca2-e053-2995a90a714b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-494-04680010494041 BOTTLE in 1 CARTON (68001-494-04) / 30 TABLET in 1 BOTTLE1 bottle2021-04-070000-00-00NoNoCurrent
68001-494-06680010494061 BOTTLE in 1 CARTON (68001-494-06) / 60 TABLET in 1 BOTTLE1 bottle2021-06-170000-00-00NoNoCurrent