FDA.reportPublic FDA data

famotidine

Product NDC
69230-327
11-digit product format
692300327
Labeler code
69230
Product ID
69230-327_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
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
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69230-327-01famotidine100 in 1 BOTTLETABLET, FILM COATED1002
69230-327-01famotidine1 in 1 CARTONTABLET, FILM COATED12
69230-327-05famotidine500 in 1 BOTTLETABLET, FILM COATED5002
69230-327-05famotidine1 in 1 CARTONTABLET, FILM COATED12
69230-327-10famotidine1000 in 1 BOTTLETABLET, FILM COATED10002
69230-327-10famotidine1 in 1 CARTONTABLET, FILM COATED12
69230-327-30famotidine1 in 1 CARTONTABLET, FILM COATED12
69230-327-30famotidine30 in 1 BOTTLETABLET, FILM COATED302
69230-327-50famotidine50 in 1 BOTTLETABLET, FILM COATED502
69230-327-50famotidine1 in 1 CARTONTABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-327-01EA - Each69230-327ee1428b2-60cb-45bb-9b5d-321ff91fd91c12022-11-07
69230-327-05EA - Each69230-327e09c35a5-3503-4bde-b557-5fd57b8f912c12022-11-07
69230-327-10EA - Each69230-3272f4fecfe-76e3-4e08-b7a6-8287161bff1c12022-11-07
69230-327-30EA - Each69230-3270ff79489-5ed0-47f3-b1d9-a814a3ede5d512022-11-07
69230-327-50EA - Each69230-327140c3870-4eec-4a25-b3c7-4a4d44a77a7912022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-327FAMOTIDINE (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
69230-327-01692300327011 BOTTLE in 1 CARTON (69230-327-01) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-080000-00-00NoNoCurrent
69230-327-05692300327051 BOTTLE in 1 CARTON (69230-327-05) / 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-080000-00-00NoNoCurrent
69230-327-10692300327101 BOTTLE in 1 CARTON (69230-327-10) / 1000 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-080000-00-00NoNoCurrent
69230-327-30692300327301 BOTTLE in 1 CARTON (69230-327-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-080000-00-00NoNoCurrent
69230-327-50692300327501 BOTTLE in 1 CARTON (69230-327-50) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-080000-00-00NoNoCurrent
69230-327-60692300327601 BOTTLE in 1 CARTON (69230-327-60) > 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-080000-00-00NoNoCurrent