FDA.reportPublic FDA data

Famotidine

Product NDC
63868-584
11-digit product format
638680584
Labeler code
63868
Product ID
63868-584_cf8df4a2-be86-9900-a859-a08b841f6a53
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association INC
Application
ANDA077367
Marketing category
ANDA
Marketing start
2020-12-01
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
Rxcui199047, 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-584-25Famotidine1 in 1 CARTONTABLET16
63868-584-25Famotidine25 in 1 BOTTLETABLET256
63868-584-50Famotidine1 in 1 CARTONTABLET16
63868-584-50Famotidine50 in 1 BOTTLETABLET506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-584-25EA - Each63868-58459f6ee3d-2a4d-45ae-a676-071b3166647b12022-10-06
63868-584-50EA - Each63868-5847f6c9b1f-cafe-4812-b26a-708134c6048312022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-584FAMOTIDINE TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]5Current NDC, Legacy NDC, 4 package rows20241024_1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a6
310273famotidine 20 MG Oral TabletPSN1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a6
199047famotidine 10 MG Oral TabletSCD1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a6
310273famotidine 20 MG Oral TabletSCD1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-584-25638680584251 BOTTLE in 1 CARTON (63868-584-25) / 25 TABLET in 1 BOTTLE1 bottle2020-12-010000-00-00NoNoCurrent
63868-584-50638680584501 BOTTLE in 1 CARTON (63868-584-50) / 50 TABLET in 1 BOTTLE1 bottle2020-12-010000-00-00NoNoCurrent