FDA.reportPublic FDA data

FAMOTIDINE

Product NDC
67877-889
11-digit product format
678770889
Labeler code
67877
Product ID
67877-889_23381364-14e1-4f63-aea4-66d605fd14f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA215630
Marketing category
ANDA
Marketing start
2023-08-23
Substance
FAMOTIDINE
Active strength
40 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
FAMOTIDINE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui284245, 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
67877-889-01FAMOTIDINE100 in 1 BOTTLETABLET, FILM COATED1005
67877-889-05FAMOTIDINE500 in 1 BOTTLETABLET, FILM COATED5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-889-05EA - Each67877-8895700624b-a087-449c-a56a-8856ed3b21d212024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-889FAMOTIDINE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]4Current NDC, 2 package rows20250131_be69d9f9-f4ad-4cfe-bab2-e07186b25c1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSN9c5dce17-1865-4aa6-89f6-24dd55b5f06c7
284245famotidine 40 MG Oral TabletSCD9c5dce17-1865-4aa6-89f6-24dd55b5f06c7
310273famotidine 20 MG Oral TabletPSNbe69d9f9-f4ad-4cfe-bab2-e07186b25c1e5
284245famotidine 40 MG Oral TabletPSNbe69d9f9-f4ad-4cfe-bab2-e07186b25c1e5
310273famotidine 20 MG Oral TabletSCDbe69d9f9-f4ad-4cfe-bab2-e07186b25c1e5
284245famotidine 40 MG Oral TabletSCDbe69d9f9-f4ad-4cfe-bab2-e07186b25c1e5
284245famotidine 40 MG Oral TabletPSNa0f38398-4d34-4ecc-8a6a-37732adaaad34
284245famotidine 40 MG Oral TabletSCDa0f38398-4d34-4ecc-8a6a-37732adaaad34
284245famotidine 40 MG Oral TabletPSN7cef62ab-1740-4d0f-b6ea-fda783e1c1973
284245famotidine 40 MG Oral TabletSCD7cef62ab-1740-4d0f-b6ea-fda783e1c1973
310273famotidine 20 MG Oral TabletPSN69bd5340-298b-46ca-83c7-0b5ef233f9c51
284245famotidine 40 MG Oral TabletPSN69bd5340-298b-46ca-83c7-0b5ef233f9c51
284245famotidine 40 MG Oral TabletPSN1dff8288-e030-16ff-e063-6394a90a23921
284245famotidine 40 MG Oral TabletPSN13168d9e-0697-e5fb-e063-6294a90a69ba1
310273famotidine 20 MG Oral TabletSCD69bd5340-298b-46ca-83c7-0b5ef233f9c51
284245famotidine 40 MG Oral TabletSCD13168d9e-0697-e5fb-e063-6294a90a69ba1
284245famotidine 40 MG Oral TabletSCD69bd5340-298b-46ca-83c7-0b5ef233f9c51
284245famotidine 40 MG Oral TabletSCD1dff8288-e030-16ff-e063-6394a90a23921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67877-889-0167877088901100 TABLET, FILM COATED in 1 BOTTLE (67877-889-01) 2023-08-23NoNoCurrent
67877-889-0567877088905500 TABLET, FILM COATED in 1 BOTTLE (67877-889-05) 2023-08-23NoNoCurrent