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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078916-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORALAB2009-05-22
A078916-002FAMOTIDINEFAMOTIDINE40MGTABLET / ORALAB2009-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A078916-001AB
A078916-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078916-001FAMOTIDINE20MGTABLET / ORALAB2009-05-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A078916-002FAMOTIDINE40MGTABLET / ORALAB2009-05-22782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078916-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078916-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078916-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078916-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078916-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078916-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078916-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078916-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078916-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078916-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078916-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078916-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078916-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078916-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078916-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078916-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078916-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078916-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078916-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078916-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078916-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078916-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078916-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078916-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078916-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078916-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078916-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078916-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078916-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078916-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078916-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078916-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078916-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078916-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078916-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078916-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078916-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078916-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078916-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078916-002AB1782e0a99824c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5QZO15J2Z8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
284245Internal RxNorm lookup
310273Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f149ecc1-d66c-42f9-a3f4-2ab6a522942bAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.32fd4101-15cb-411e-8b9d-270ec0592c6e2026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
FamotidineFAMOTIDINEBryant Ranch Prepackcf2cd30e-9a0f-4b63-975c-5b551691cda92026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
FamotidineFAMOTIDINEBryant Ranch Prepackdb3af7cc-efc6-4934-acff-8bb2d31fe8292026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
FamotidineFAMOTIDINEAlembic Pharmaceuticals Inc.f149ecc1-d66c-42f9-a3f4-2ab6a522942b2026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
ndc (product): 62332-001
FamotidineFAMOTIDINENorthwind Health Company, LLC43454e0f-4e1e-bbc6-e063-6394a90a5ac42025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
FamotidineFAMOTIDINENCS HealthCare of KY, LLC dba Vangard Labs59b17677-d805-4d9e-9c64-96385ae47bff2025-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
FAMOTIDINEFAMOTIDINEdirect rxb1b82d2a-cdb5-3e22-e053-2995a90a917d2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
FamotidineFAMOTIDINEAlembic Pharmaceuticals Limited7c0f3fa5-0a44-4a98-bc43-8bff8e95c4622024-10-31Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
FamotidineFAMOTIDINENuCare Pharmaceuticals, Inc.4b820924-24ad-4a2f-e054-00144ff88e882024-07-19Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
FamotidineFAMOTIDINEProficient Rx LP9baf2596-b771-4bae-a03c-d3af6716821d2022-05-02Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
FamotidineFAMOTIDINEAphena Pharma Solutions - Tennessee, LLCb1839d23-20f4-4651-a7d2-8bc3a75839172020-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
FamotidineFAMOTIDINEProficient Rx LP92048836-e692-4ce1-93f4-88b00acabcde2019-11-01Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916

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