FDA.reportPublic FDA data

famotidine

Product NDC
69230-326
11-digit product format
692300326
Labeler code
69230
Product ID
69230-326_eabd2ff8-a7d9-2ac4-e053-2995a90a3b40
Type
HUMAN OTC DRUG
Nonproprietary name
famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Consumer Care Inc
Application
ANDA215766
Marketing category
ANDA
Marketing start
2021-11-08
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, 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
69230-326-01famotidine1 in 1 CARTONTABLET, FILM COATED12
69230-326-01famotidine100 in 1 BOTTLETABLET, FILM COATED1002
69230-326-05famotidine500 in 1 BOTTLETABLET, FILM COATED5002
69230-326-05famotidine1 in 1 CARTONTABLET, FILM COATED12
69230-326-10famotidine1 in 1 CARTONTABLET, FILM COATED12
69230-326-10famotidine1000 in 1 BOTTLETABLET, FILM COATED10002
69230-326-30famotidine30 in 1 BOTTLETABLET, FILM COATED302
69230-326-30famotidine1 in 1 CARTONTABLET, FILM COATED12
69230-326-60famotidine1 in 1 CARTONTABLET, FILM COATED12
69230-326-60famotidine60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-326-01EA - Each69230-326518bb868-14fc-4091-afc7-07ea90dfc57012022-11-07
69230-326-05EA - Each69230-326a1f54079-51ca-46df-9d83-cd10852434ba12022-11-07
69230-326-10EA - Each69230-326d7453e8d-c651-4d46-a240-779bdbe4717112022-11-07
69230-326-30EA - Each69230-3260512ff0b-532f-4e4e-8e08-7cc65f73afc712022-11-07
69230-326-60EA - Each69230-326f29b8820-844e-4ff6-ab07-497a990dcd8012022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-326FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [CAMBER CONSUMER CARE INC]2Current NDC, Legacy NDC, 10 package rows20221012_ebe3ca30-df25-4c56-8935-414a3431b5b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSNebe3ca30-df25-4c56-8935-414a3431b5b92
310273famotidine 20 MG Oral TabletPSNebe3ca30-df25-4c56-8935-414a3431b5b92
199047famotidine 10 MG Oral TabletSCDebe3ca30-df25-4c56-8935-414a3431b5b92
310273famotidine 20 MG Oral TabletSCDebe3ca30-df25-4c56-8935-414a3431b5b92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-326-01692300326011 BOTTLE in 1 CARTON (69230-326-01) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-080000-00-00NoNoCurrent
69230-326-05692300326051 BOTTLE in 1 CARTON (69230-326-05) / 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-080000-00-00NoNoCurrent
69230-326-10692300326101 BOTTLE in 1 CARTON (69230-326-10) / 1000 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-080000-00-00NoNoCurrent
69230-326-30692300326301 BOTTLE in 1 CARTON (69230-326-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-080000-00-00NoNoCurrent
69230-326-33692300326337 POUCH in 1 DRUM (69230-326-33) / 10000 TABLET, FILM COATED in 1 POUCH7 pouch08-NOV-21Current
69230-326-50692300326501 BOTTLE in 1 CARTON (69230-326-50) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-080000-00-00NoNoCurrent
69230-326-60692300326601 BOTTLE in 1 CARTON (69230-326-60) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-080000-00-00NoNoCurrent