FDA.reportPublic FDA data

Famotidine

Product NDC
62332-001
11-digit product format
623320001
Labeler code
62332
Product ID
62332-001_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
20 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
FAMOTIDINE20 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
62332-001-10Famotidine100 in 1 CARTONTABLET10013
62332-001-30Famotidine30 in 1 BOTTLETABLET3013
62332-001-31Famotidine100 in 1 BOTTLETABLET10013
62332-001-71Famotidine500 in 1 BOTTLETABLET50013
62332-001-91Famotidine1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-001-31EA - Each62332-0013bb1267e-d5ae-497b-a3d4-d3702f0de8aa12016-03-04
62332-001-91EA - Each62332-0019e4e25aa-5fdb-4e9d-a6b9-99865daeefa112016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-001FAMOTIDINE 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 TabletPSNcf2cd30e-9a0f-4b63-975c-5b551691cda9102
310273famotidine 20 MG Oral TabletSCDcf2cd30e-9a0f-4b63-975c-5b551691cda9102
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
310273famotidine 20 MG Oral TabletPSN9baf2596-b771-4bae-a03c-d3af6716821d6
310273famotidine 20 MG Oral TabletSCD9baf2596-b771-4bae-a03c-d3af6716821d6
310273famotidine 20 MG Oral TabletPSN50597369-cb08-5a5b-e054-00144ff88e885
310273famotidine 20 MG Oral TabletPSN4b820924-24ad-4a2f-e054-00144ff88e885
310273famotidine 20 MG Oral TabletSCD50597369-cb08-5a5b-e054-00144ff88e885
310273famotidine 20 MG Oral TabletSCD4b820924-24ad-4a2f-e054-00144ff88e885
310273famotidine 20 MG Oral TabletPSN3ed93a3b-fefc-40cf-aeac-7ef38844a5393
310273famotidine 20 MG Oral TabletPSN43454e0f-4e1e-bbc6-e063-6394a90a5ac43
310273famotidine 20 MG Oral TabletPSNb1b82d2a-cdb5-3e22-e053-2995a90a917d3
310273famotidine 20 MG Oral TabletSCD3ed93a3b-fefc-40cf-aeac-7ef38844a5393
310273famotidine 20 MG Oral TabletSCD43454e0f-4e1e-bbc6-e063-6394a90a5ac43
310273famotidine 20 MG Oral TabletSCDb1b82d2a-cdb5-3e22-e053-2995a90a917d3
310273famotidine 20 MG Oral TabletPSN1fa09253-1c3e-4378-bb3e-c732f92c3ae92
310273famotidine 20 MG Oral TabletPSNb1839d23-20f4-4651-a7d2-8bc3a75839172
310273famotidine 20 MG Oral TabletSCDb1839d23-20f4-4651-a7d2-8bc3a75839172
310273famotidine 20 MG Oral TabletSCD1fa09253-1c3e-4378-bb3e-c732f92c3ae92
310273famotidine 20 MG Oral TabletPSN9ff330bd-a6e6-1dd6-e053-2995a90a63f21
310273famotidine 20 MG Oral TabletPSN59b17677-d805-4d9e-9c64-96385ae47bff1
284245famotidine 40 MG Oral TabletPSN59b17677-d805-4d9e-9c64-96385ae47bff1
310273famotidine 20 MG Oral TabletSCD9ff330bd-a6e6-1dd6-e053-2995a90a63f21
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
62332-001-1062332000110100 TABLET in 1 CARTON (62332-001-10) 100 tablet2016-01-290000-00-00NoNoCurrent
62332-001-306233200013030 TABLET in 1 BOTTLE (62332-001-30) 30 tablet2016-01-290000-00-00NoNoCurrent
62332-001-3162332000131100 TABLET in 1 BOTTLE (62332-001-31) 100 tablet2016-01-290000-00-00NoNoCurrent
62332-001-7162332000171500 TABLET in 1 BOTTLE (62332-001-71) 500 tablet2016-01-290000-00-00NoNoCurrent
62332-001-91623320001911000 TABLET in 1 BOTTLE (62332-001-91) 1000 tablet2016-01-290000-00-00NoNoCurrent