FDA.reportPublic FDA data

Famotidine 10 mg

Product NDC
25000-086
11-digit product format
250000086
Labeler code
25000
Product ID
25000-086_c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine 10 mg
Dosage form
TABLET, COATED
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA217543
Marketing category
ANDA
Marketing start
2023-03-10
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 10 mg
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
25000-086-03Famotidine 10 mg30 in 1 BOTTLETABLET, COATED305
25000-086-03Famotidine 10 mg1 in 1 CARTONTABLET, COATED15
25000-086-07Famotidine 10 mg90 in 1 BOTTLETABLET, COATED905
25000-086-07Famotidine 10 mg1 in 1 CARTONTABLET, COATED15
25000-086-08Famotidine 10 mg1 in 1 CARTONTABLET, COATED15
25000-086-08Famotidine 10 mg100 in 1 BOTTLETABLET, COATED1005
25000-086-36Famotidine 10 mg3 in 1 CARTONTABLET, COATED35
25000-086-36Famotidine 10 mg10 in 1 BLISTER PACKTABLET, COATED105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-086FAMOTIDINE 10 MG TABLET, COATED FAMOTIDINE 20 MG TABLET, COATED [MARKSANS PHARMA LIMITED]5Current NDC, 8 package rows20250325_58b653eb-6539-4b79-9d22-df6eaf35307f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN58b653eb-6539-4b79-9d22-df6eaf35307f5
310273famotidine 20 MG Oral TabletPSN58b653eb-6539-4b79-9d22-df6eaf35307f5
199047famotidine 10 MG Oral TabletSCD58b653eb-6539-4b79-9d22-df6eaf35307f5
310273famotidine 20 MG Oral TabletSCD58b653eb-6539-4b79-9d22-df6eaf35307f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25000-086-03250000086031 BOTTLE in 1 CARTON (25000-086-03) / 30 TABLET, COATED in 1 BOTTLE1 bottle2023-03-10NoNoCurrent
25000-086-07250000086071 BOTTLE in 1 CARTON (25000-086-07) / 90 TABLET, COATED in 1 BOTTLE1 bottle2024-04-24NoNoCurrent
25000-086-08250000086081 BOTTLE in 1 CARTON (25000-086-08) / 100 TABLET, COATED in 1 BOTTLE1 bottle2023-03-10NoNoCurrent
25000-086-36250000086363 BLISTER PACK in 1 CARTON (25000-086-36) / 10 TABLET, COATED in 1 BLISTER PACK3 blister pack2023-03-10NoNoCurrent