Famotidine

Product NDC
50268-303
Requested package NDC
50268-303-15
11-digit product format
502680303
Labeler code
50268
Product ID
50268-303_d5cef7b8-4da8-4a5d-e053-2a95a90a21d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA075805
Marketing category
ANDA
Marketing start
2014-10-06
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50268-30350268-303-15DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A075805-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORALAB2001-04-16
A075805-002FAMOTIDINEFAMOTIDINE40MGTABLET / 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
A075805-001AB
A075805-002AB

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 UTC2026-02A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A075805-002FAMOTIDINE40MGTABLET / 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 UTC2026-02A075805-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075805-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075805-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075805-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075805-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075805-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075805-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075805-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075805-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075805-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075805-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075805-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075805-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075805-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075805-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075805-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075805-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075805-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075805-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075805-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075805-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075805-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075805-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075805-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075805-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075805-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075805-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075805-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075805-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075805-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075805-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075805-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075805-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075805-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075805-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075805-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075805-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075805-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075805-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075805-002AB1782e0a99824c…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-303-11Famotidine1 in 1 BLISTER PACKTABLET17
50268-303-15Famotidine50 in 1 BOX, UNIT-DOSETABLET507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-303-11EA - Each50268-30389399e16-36ad-46bf-8695-487957b3ebf612015-04-03
50268-303-15EA - Each50268-303b0b99c0f-5d9a-44f8-b93f-7f58c5d1bec112015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FamotidineACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
FamotidineACTIVE MOIETY5QZO15J2Z8FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
magnesium stearateINACTIVE INGREDIENT70097M6I30FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
polydextroseINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
starch, cornINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
talcINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
triacetinINACTIVE INGREDIENTXHX3C3X673FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-303FAMOTIDINE TABLET [AVPAK]6Legacy NDC, 2 package rows20240502_85c7d20d-3dec-b918-4c1d-8ca1db214e48.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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEA-S Medication Solutionsd0558e97-3bc3-4a1e-9248-1959b03440232026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINENorthwind Health Company, LLCab1cdbbf-d838-020c-e053-2995a90a0f652026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEAvPAK85c7d20d-3dec-b918-4c1d-8ca1db214e482025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
ndc (package): 50268-303-15
ndc (product): 50268-303
ndc11 (package): 50268030315
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.66f0bf15-ff35-426a-b40c-0d0da79d08612025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.09ef39a4-c6b3-4395-8211-3f551dc448302025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FAMOTIDINEFAMOTIDINEdirect rxc3de241e-6217-d6e0-e053-2a95a90a35c52025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEGolden State Medical Supply, Inc.f67bcbc7-952c-61c0-e053-2a95a90a6fa62024-09-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEBryant Ranch Prepack67a6e7f3-04d6-426c-b952-7677a84ace4d2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEBryant Ranch Prepack3031c7d1-5a4e-42b3-a3ca-9ac2ea2f76fb2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEBryant Ranch Prepack92a75aa6-3c63-4c98-be8e-dcd03affc10b2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEBryant Ranch Prepack81f24752-3474-3013-0013-5570c8e7baf72024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEBryant Ranch Prepack82930f64-4556-491f-96cc-270be9e3589a2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINECarlsbad Technology, Inca8b5c855-053d-4295-8f57-1a96a6ccaa922024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINENuCare Pharmaceuticals,Inc.b556d1a8-4155-50cf-e053-2995a90a9b142024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINENuCare Pharmaceuticals,Inc.60cd0973-f74e-2b70-e053-2a91aa0a43612024-06-06Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
PepcidFAMOTIDINEBausch Health US LLCa06502d9-7903-4f37-833e-e5763d502def2024-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEA-S Medication Solutionsae3646c7-76fc-473d-b20b-67d3c6ac0b752023-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEProficient Rx LPc84b0ba3-1ba8-4da9-b5b8-186e01cda9992022-07-01Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEAphena Pharma Solutions - Tennessee, LLC46c6d243-eefc-40ca-8bd4-4c89456f635f2021-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEProficient Rx LP1e2003d4-09a3-4cc8-af3d-93d29b9123c02020-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN85c7d20d-3dec-b918-4c1d-8ca1db214e487
284245famotidine 40 MG Oral TabletPSN85c7d20d-3dec-b918-4c1d-8ca1db214e487
310273famotidine 20 MG Oral TabletSCD85c7d20d-3dec-b918-4c1d-8ca1db214e487
284245famotidine 40 MG Oral TabletSCD85c7d20d-3dec-b918-4c1d-8ca1db214e487

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-303-155026803031550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-303-15) > 1 TABLET in 1 BLISTER PACK (50268-303-11) 50 blister pack2014-10-060000-00-00NoNoCurrent