FAMOTIDINE

Product NDC
60760-843
11-digit product format
607600843
Labeler code
60760
Product ID
60760-843_50c43530-2461-ff82-e063-6394a90a6c4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA215630
Marketing category
ANDA
Marketing start
2022-07-08
Substance
FAMOTIDINE
Active strength
40 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

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 packagepackage60760-84360760-843-60DDiscontinued by firm2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A215630-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORALAB2022-01-07
A215630-002FAMOTIDINEFAMOTIDINE40MGTABLET / ORALAB2022-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215630-001AB
A215630-002AB

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 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-0784e616aacf4f…
2026-09-14 22:38:342026-08A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-0784e616aacf4f…
2026-08-18 06:07:402026-07A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07caaa826d4ba7…
2026-08-18 06:07:402026-07A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-074b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215630-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A215630-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A215630-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215630-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215630-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215630-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215630-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215630-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215630-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215630-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215630-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215630-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215630-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215630-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215630-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215630-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215630-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215630-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215630-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215630-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215630-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215630-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215630-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215630-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215630-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215630-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215630-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215630-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215630-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215630-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215630-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215630-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215630-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215630-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215630-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215630-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215630-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A215630-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215630-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A215630-002AB1bb7c543d1eb4…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
FAMOTIDINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE40 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
febe39b1-9212-a281-e053-6394a90a1a9fAvailable 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
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-843-07FAMOTIDINE7 in 1 BOTTLE, PLASTICTABLET, FILM COATED72
60760-843-60FAMOTIDINE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-843-07EA - Each60760-843239768e7-839a-4d82-9897-fcd1d085358612023-08-08
60760-843-60EA - Each60760-843082155cd-cfc7-41f9-a115-998fcb17641212023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-843FAMOTIDINE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 2 package rows20230718_febe39b1-9212-a281-e053-6394a90a1a9f.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.9c5dce17-1865-4aa6-89f6-24dd55b5f06c2026-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEPD-Rx Pharmaceuticals, Inc.a0f38398-4d34-4ecc-8a6a-37732adaaad32026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEHAWAII REPACK, INC.eec89230-47fc-4139-a370-b4f9e225e8c02026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.e59a2c97-19c7-485c-bb1b-272ddb9ae0532026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEA-S Medication Solutionse53928f3-5181-490b-acfb-be8d4cea60a92026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEA-S Medication Solutions05b47b1d-f7f3-4dae-9b22-d43d2a7cfaef2026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEST. MARY'S MEDICAL PARK PHARMACYfebe39b1-9212-a281-e053-6394a90a1a9f2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
ndc (product): 60760-843
FAMOTIDINEFAMOTIDINEPreferred Pharmaceuticals Inc.b445a613-eaa8-45e8-be1f-5848bfd1dd362026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEPreferred Pharmaceuticals Inc.dbf94314-3a34-4f03-80b1-296559b7d6a52026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.3ab235f4-da59-4a92-ad6b-c76cf3ecd9852026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEA-S Medication Solutions74a69baa-a7c5-4e67-8db6-2ec39ab6cfe52025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEBryant Ranch Prepack7cef62ab-1740-4d0f-b6ea-fda783e1c1972025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEA-S Medication Solutions3c32f8e2-f54a-422d-9c25-68692ea090012025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEPD-Rx Pharmaceuticals, Inc.a3b50576-cd40-4f7e-9506-bd0a619884242025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEAscend Laboratories, LLCbe69d9f9-f4ad-4cfe-bab2-e07186b25c1e2025-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEBryant Ranch Prepacka24e8f45-6ace-4a81-8005-c23a55dadd9a2025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINENuCare Pharmceuticals,Inc.fc603d56-6828-8c5e-e053-6394a90a35bd2025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEBryant Ranch Prepack077bb160-e616-4863-bdde-989140f99e1c2024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINENuCare Pharmaceuticals,Inc.fd271deb-c748-bf26-e053-6294a90a11aa2024-06-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEAsclemed USA, Inc.69bd5340-298b-46ca-83c7-0b5ef233f9c52024-04-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSNfebe39b1-9212-a281-e053-6394a90a1a9f2
284245famotidine 40 MG Oral TabletSCDfebe39b1-9212-a281-e053-6394a90a1a9f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-843-07607600843077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-843-07) 2023-06-20NoNoCurrent
60760-843-606076008436060 in 1 BOTTLE, PLASTICHistorical