Famotidine

Product NDC
68071-2678
11-digit product format
680712678
Labeler code
68071
Product ID
68071-2678_dd7f7b98-c284-ba34-e053-2995a90a523e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA075718
Marketing category
ANDA
Marketing start
2001-04-16
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2678IInactivated by FDA2026-08-03
excluded packagepackage68071-267868071-2678-3IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2678-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2678-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2678-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2678-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2678-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2678-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2678-3UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2678-3UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2678-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A075718-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORALAB2001-04-16
A075718-002FAMOTIDINEFAMOTIDINE40MGTABLET / ORALAB2001-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075718-001AB
A075718-002AB

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 UTC2026-02A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075718-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A075718-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16782e0a99824c…

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 UTC2026-02A075718-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075718-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075718-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075718-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075718-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075718-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075718-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075718-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075718-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075718-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075718-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075718-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075718-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075718-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075718-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075718-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075718-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075718-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075718-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075718-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075718-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075718-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075718-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075718-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075718-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075718-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075718-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075718-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075718-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075718-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075718-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075718-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075718-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075718-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075718-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075718-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075718-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075718-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075718-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075718-002AB1782e0a99824c…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2678-3Famotidine30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2678FAMOTIDINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220426_dd7f7c04-aeaa-4629-e053-2995a90a4341.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
FamotidineFAMOTIDINESportpharm LLC4421ceb7-a114-436c-871a-7bc5444f81542026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075718
application number: ANDA075718
FamotidineFAMOTIDINEProficient Rx LP68d21d95-9603-4e68-855a-bfc65b1b58c32026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075718
application number: ANDA075718
FamotidineFAMOTIDINECardinal Health 107, LLC5d515c2a-dac9-42d8-aede-66d28a427dbc2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075718
application number: ANDA075718
FamotidineFAMOTIDINECardinal Health 107, LLCcdd5dfb7-4efb-4235-8023-5ce145c090382026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075718
application number: ANDA075718
FamotidineFAMOTIDINEBryant Ranch Prepack545d5c1f-ec1c-4135-965f-333ad888d96f2026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075718
application number: ANDA075718
FamotidineFAMOTIDINELegacy Pharmaceutical Packaging, LLCcc88fbdc-546e-332f-e053-2995a90a8ca72026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075718
application number: ANDA075718
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.5ed77259-5dd9-4634-a073-346693488c4f2025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075718
application number: ANDA075718
FamotidineFAMOTIDINEMajor Pharmaceuticals3e6d167f-91e4-4122-911d-d3da66386f442025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075718
application number: ANDA075718
FamotidineFAMOTIDINEAvPAKdfdca61d-8824-6230-e053-2995a90a209d2025-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075718
application number: ANDA075718
FamotidineFAMOTIDINEQuality Care Products, LLC3549386a-533d-4e44-8097-f6bc51ee494a2024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075718
application number: ANDA075718
FamotidineFAMOTIDINEDirect_Rx138d9ed1-2f8f-d19d-e063-6394a90a695d2024-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075718
application number: ANDA075718
FamotidineFAMOTIDINEDr.Reddy's Laboratories Limited06d286ce-14b3-4b66-8b42-ac4a10a0fc902020-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075718
application number: ANDA075718

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNdd7f7c04-aeaa-4629-e053-2995a90a43411
310273famotidine 20 MG Oral TabletSCDdd7f7c04-aeaa-4629-e053-2995a90a43411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2678-36807126780330 TABLET, FILM COATED in 1 BOTTLE (68071-2678-3) 2022-04-250000-00-00NoNoCurrent