Famotidine

Product NDC
0615-4582
11-digit product format
006154582
Labeler code
0615
Product ID
0615-4582_b936bdb0-9b96-4f47-9f5d-53f363a6a2ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA075511
Marketing category
ANDA
Marketing start
2010-04-30
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-4582DDiscontinued by firm2026-08-03
excluded packagepackage0615-45820615-4582-05DDiscontinued by firm2026-08-03
excluded packagepackage0615-45820615-4582-31DDiscontinued by firm2026-08-03
excluded packagepackage0615-45820615-4582-39DDiscontinued 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 · 15 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-4582-39d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-4582-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-4582-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-4582-31f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-4582-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-4582-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-4582-31cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-4582-31cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-4582-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-4582-31ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-4582-310efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-4582-31ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-4582-31367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-4582-31557ba5c1ecfa…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
A075511-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORALAB2001-04-16
A075511-002FAMOTIDINEFAMOTIDINE40MGTABLET / 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
A075511-001AB
A075511-002AB

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 UTC2026-02A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A075511-002FAMOTIDINE40MGTABLET / 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 UTC2026-02A075511-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075511-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075511-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075511-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075511-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075511-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075511-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075511-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075511-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075511-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075511-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075511-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075511-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075511-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075511-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075511-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075511-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075511-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075511-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075511-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075511-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075511-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075511-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075511-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075511-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075511-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075511-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075511-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075511-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075511-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075511-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075511-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075511-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075511-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075511-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075511-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075511-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075511-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075511-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075511-002AB1782e0a99824c…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
TRIACETININACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-4582FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]10Legacy NDC20241207_8be0d6bb-172c-46c5-b887-12c0faa6db9b.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEProficient Rx LPd60bde93-f512-4071-9e4b-1d8318def3bc2026-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
FamotidineFAMOTIDINENorthwind Health Company, LLCf2b6da72-72ea-d81b-e053-2995a90a95262026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
FamotidineFAMOTIDINENorthwind Health Company, LLC03503cd5-bd8e-4bff-b90d-1a71c5225b912025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.5798d282-ce83-49aa-bc33-13203f2b52852025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
FamotidineFAMOTIDINEA-S Medication Solutions2bde8e1d-078f-4ba1-9ccb-29de6e36d8c42023-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
FamotidineFAMOTIDINEA-S Medication Solutions74ff64f2-d882-411f-bac8-29dfa4cb4f102023-08-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
FamotidineFAMOTIDINEProficient Rx LPfe21daca-ac48-4b46-9cb3-9a69af0c6a842023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
FamotidineFAMOTIDINETeva Pharmaceuticals USA, Inc.4c6f4f9e-f3f5-4ecf-9f40-887e037e88472019-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-4582-050061545820515 TABLET, FILM COATED in 1 BLISTER PACK (0615-4582-05) 2010-04-300000-00-00NoNoCurrent
0615-4582-390061545823930 TABLET, FILM COATED in 1 BLISTER PACK (0615-4582-39) 2010-04-300000-00-00NoNoCurrent