FDA.reportPublic FDA data

Pepcid

Product NDC
0187-4420
11-digit product format
001874420
Labeler code
0187
Product ID
0187-4420_7d2d8240-b53a-4395-bd8d-d326522d5865
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bausch Health US LLC
Application
ANDA075805
Marketing category
ANDA
Marketing start
2001-04-16
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
Pepcid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui104094, 104095, 284245, 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
0187-4420-10Pepcid100 in 1 BOTTLETABLET, FILM COATED1008
0187-4420-30Pepcid30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-4420-10EA - Each0187-4420988333d8-9ffa-4310-9d5b-4049468ec3e312016-11-08
0187-4420-30EA - Each0187-4420bf9411b7-de7e-4e3e-85b9-f26ffa843dec12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-4420PEPCID (FAMOTIDINE) TABLET, FILM COATED [BAUSCH HEALTH US LLC]8Current NDC, Legacy NDC, 2 package rows20240809_a06502d9-7903-4f37-833e-e5763d502def.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNa06502d9-7903-4f37-833e-e5763d502def8
284245famotidine 40 MG Oral TabletPSNa06502d9-7903-4f37-833e-e5763d502def8
104095Pepcid 40 MG Oral TabletPSNa06502d9-7903-4f37-833e-e5763d502def8
104094Pepcid AC 20 MG Oral TabletPSNa06502d9-7903-4f37-833e-e5763d502def8
104094famotidine 20 MG Oral Tablet [Pepcid]SBDa06502d9-7903-4f37-833e-e5763d502def8
104095famotidine 40 MG Oral Tablet [Pepcid]SBDa06502d9-7903-4f37-833e-e5763d502def8
310273famotidine 20 MG Oral TabletSCDa06502d9-7903-4f37-833e-e5763d502def8
284245famotidine 40 MG Oral TabletSCDa06502d9-7903-4f37-833e-e5763d502def8
104094Pepcid 20 MG Oral TabletSYa06502d9-7903-4f37-833e-e5763d502def8
104095Pepcid 40 MG Oral TabletSYa06502d9-7903-4f37-833e-e5763d502def8
104094Pepcid AC 20 MG Oral TabletSYa06502d9-7903-4f37-833e-e5763d502def8
104095Pepcid AC 40 MG Oral TabletSYa06502d9-7903-4f37-833e-e5763d502def8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0187-4420-1000187442010100 TABLET, FILM COATED in 1 BOTTLE (0187-4420-10) 2001-04-160000-00-00NoNoCurrent
0187-4420-300018744203030 TABLET, FILM COATED in 1 BOTTLE (0187-4420-30) 2001-04-160000-00-00NoNoCurrent