Application 078916

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAMOTIDINEFAMOTIDINETABLET;ORAL20MGNoNo
002FAMOTIDINEFAMOTIDINETABLET;ORAL40MGNoNo

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…

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
ndc (product): 71335-0409
FamotidineFAMOTIDINEBryant Ranch Prepackdb3af7cc-efc6-4934-acff-8bb2d31fe8292026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
ndc (product): 71335-0231
FamotidineFAMOTIDINEAlembic Pharmaceuticals Inc.f149ecc1-d66c-42f9-a3f4-2ab6a522942b2026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
ndc (product): 62332-001
ndc (product): 62332-002
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
ndc (product): 72189-141
FamotidineFAMOTIDINEAlembic Pharmaceuticals Limited7c0f3fa5-0a44-4a98-bc43-8bff8e95c4622024-10-31Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
ndc (product): 46708-294
ndc (product): 46708-293
FamotidineFAMOTIDINENuCare Pharmaceuticals, Inc.4b820924-24ad-4a2f-e054-00144ff88e882024-07-19Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
ndc (product): 68071-3201
FamotidineFAMOTIDINEProficient Rx LP9baf2596-b771-4bae-a03c-d3af6716821d2022-05-02Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
ndc (product): 63187-723
FamotidineFAMOTIDINEAphena Pharma Solutions - Tennessee, LLCb1839d23-20f4-4651-a7d2-8bc3a75839172020-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
ndc (product): 71610-399
FamotidineFAMOTIDINEProficient Rx LP92048836-e692-4ce1-93f4-88b00acabcde2019-11-01Adverse reactionsExact identifier
application applno (ANDA): 078916
application number: ANDA078916
ndc (product): 63187-908

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 77 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-293FamotidineFamotidineAlembic Pharmaceuticals LimitedANDACurrent
46708-293FamotidineFamotidineAlembic Pharmaceuticals LimitedANDACurrent
46708-294FamotidineFamotidineAlembic Pharmaceuticals LimitedANDACurrent
46708-294FamotidineFamotidineAlembic Pharmaceuticals LimitedANDACurrent
50436-1000FamotidineFamotidineUnit Dose ServicesANDACurrent
53002-1199FamotidineFamotidineRPK Pharmaceuticals, Inc.ANDACurrent
53002-1199FamotidineFamotidineRPK Pharmaceuticals, Inc.ANDACurrent
60760-070FamotidineFamotidineSt. Mary's Medical Park PharmacyANDACurrent
60760-070FamotidineFamotidineSt. Mary's Medical Park PharmacyANDACurrent
61919-236FAMOTIDINEFAMOTIDINEDIRECT RXANDACurrent
61919-236FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
61919-236FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
61919-236FAMOTIDINEFAMOTIDINEDIRECT RXANDACurrent
61919-236FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
61919-236FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
62332-001FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-001FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-001FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-001FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-001FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-002FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-002FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-002FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-002FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-002FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
63187-723FamotidineFamotidineProficient Rx LPANDACurrent
63187-723FamotidineFamotidineProficient Rx LPANDACurrent
63187-723FamotidineFamotidineProficient Rx LPANDACurrent
63187-723FamotidineFamotidineProficient Rx LPANDACurrent
63187-908FamotidineFamotidineProficient Rx LPANDACurrent
63187-908FamotidineFamotidineProficient Rx LPANDACurrent
63629-7926FamotidineFamotidineBryant Ranch PrepackANDACurrent
63629-7926FamotidineFamotidineBryant Ranch PrepackANDACurrent
63629-7926FamotidineFamotidineBryant Ranch PrepackANDACurrent
66267-543FamotidineFamotidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-543FamotidineFamotidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-648FamotidineFamotidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-648FamotidineFamotidineNuCare Pharmaceuticals, Inc.ANDACurrent
67046-412FamotidineFamotidineCoupler EnterprisesANDACurrent
67296-1383FamotidineFamotidineRedPharm Drug, Inc.ANDACurrent
67296-1383FamotidineFamotidineRedPharm Drug, Inc.ANDACurrent
67296-1383FamotidineFamotidineRedPharm Drug, Inc.ANDACurrent
68001-240FamotidineFamotidineBluePoint LaboratoriesANDACurrent
68001-240FamotidineFamotidineBluePoint LaboratoriesANDACurrent
68001-241FamotidineFamotidineBluePoint LaboratoriesANDACurrent
68001-241FamotidineFamotidineBluePoint LaboratoriesANDACurrent
68071-3201FamotidineFamotidineNuCare Pharmaceuticals, IANDACurrent
68071-3201FamotidineFamotidineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3201FamotidineFamotidineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3305FamotidineFamotidineNuCare Pharmaceutical, Inc.ANDACurrent
68071-3305FamotidineFamotidineNuCare Pharmaceutical, Inc.ANDACurrent
68071-3305FamotidineFamotidineNuCare Pharmaceutical, Inc.ANDACurrent
68788-6859FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-6859FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-6859FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-6859FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-6859FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7191FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7191FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7191FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7191FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7191FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
70518-2469FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70934-540FamotidineFamotidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-540FamotidineFamotidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-540FamotidineFamotidineDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-553FamotidineFamotidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-553FamotidineFamotidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0231FamotidineFamotidineBryant Ranch PrepackANDACurrent
71335-0231FamotidineFamotidineBryant Ranch PrepackANDACurrent
71335-0409FamotidineFamotidineBryant Ranch PrepackANDACurrent
71335-0409FamotidineFamotidineBryant Ranch PrepackANDACurrent
71335-0409FamotidineFamotidineBryant Ranch PrepackANDACurrent
71610-399FamotidineFamotidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-399FamotidineFamotidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-141FAMOTIDINEFAMOTIDINEdirect rxANDACurrent
72189-141FAMOTIDINEFAMOTIDINEdirect rxANDACurrent