FDA.reportPublic FDA data

Famotidine

Product NDC
62332-002
11-digit product format
623320002
Labeler code
62332
Product ID
62332-002_bd221da3-ca77-4407-856b-489a8903c842
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA078916
Marketing category
ANDA
Marketing start
2016-01-29
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Famotidine
Listing expiration
2027-12-31

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-002-10Famotidine100 in 1 CARTONTABLET10013
62332-002-30Famotidine30 in 1 BOTTLETABLET3013
62332-002-31Famotidine100 in 1 BOTTLETABLET10013
62332-002-71Famotidine500 in 1 BOTTLETABLET50013
62332-002-91Famotidine1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-002-31EA - Each62332-002f2b63269-3404-46eb-b244-9236c80f5c5112016-03-04
62332-002-71EA - Each62332-002626f49d7-c74d-47e2-8e7b-6c663bee161212016-03-04
62332-002-91EA - Each62332-0027cd841cf-ff97-4127-a918-774013c8f32812016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-002FAMOTIDINE TABLET [ALEMBIC PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 5 package rows20241127_f149ecc1-d66c-42f9-a3f4-2ab6a522942b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNf149ecc1-d66c-42f9-a3f4-2ab6a522942b13
284245famotidine 40 MG Oral TabletPSNf149ecc1-d66c-42f9-a3f4-2ab6a522942b13
310273famotidine 20 MG Oral TabletSCDf149ecc1-d66c-42f9-a3f4-2ab6a522942b13
284245famotidine 40 MG Oral TabletSCDf149ecc1-d66c-42f9-a3f4-2ab6a522942b13
284245famotidine 40 MG Oral TabletPSNdb3af7cc-efc6-4934-acff-8bb2d31fe82910
284245famotidine 40 MG Oral TabletSCDdb3af7cc-efc6-4934-acff-8bb2d31fe82910
284245famotidine 40 MG Oral TabletPSN8fa0d2d3-79c8-358c-e053-2995a90a94355
284245famotidine 40 MG Oral TabletSCD8fa0d2d3-79c8-358c-e053-2995a90a94355
284245famotidine 40 MG Oral TabletPSN92048836-e692-4ce1-93f4-88b00acabcde3
284245famotidine 40 MG Oral TabletSCD92048836-e692-4ce1-93f4-88b00acabcde3
310273famotidine 20 MG Oral TabletPSN59b17677-d805-4d9e-9c64-96385ae47bff1
284245famotidine 40 MG Oral TabletPSN59b17677-d805-4d9e-9c64-96385ae47bff1
310273famotidine 20 MG Oral TabletSCD59b17677-d805-4d9e-9c64-96385ae47bff1
284245famotidine 40 MG Oral TabletSCD59b17677-d805-4d9e-9c64-96385ae47bff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-002-1062332000210100 TABLET in 1 CARTON (62332-002-10) 100 tablet2016-01-290000-00-00NoNoCurrent
62332-002-306233200023030 TABLET in 1 BOTTLE (62332-002-30) 30 tablet2016-01-290000-00-00NoNoCurrent
62332-002-3162332000231100 TABLET in 1 BOTTLE (62332-002-31) 100 tablet2016-01-290000-00-00NoNoCurrent
62332-002-7162332000271500 TABLET in 1 BOTTLE (62332-002-71) 500 tablet2016-01-290000-00-00NoNoCurrent
62332-002-91623320002911000 TABLET in 1 BOTTLE (62332-002-91) 1000 tablet2016-01-290000-00-00NoNoCurrent