FAMOTIDINE

Product NDC
71335-2442
11-digit product format
713352442
Labeler code
71335
Product ID
71335-2442_41dac660-35a6-dc43-e063-6394a90a6de7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215630
Marketing category
ANDA
Marketing start
2023-08-23
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
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
FAMOTIDINE
Listing expiration
2026-12-31

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
7cef62ab-1740-4d0f-b6ea-fda783e1c197Available 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
71335-2442-1FAMOTIDINE30 in 1 BOTTLETABLET, FILM COATED303
71335-2442-2FAMOTIDINE60 in 1 BOTTLETABLET, FILM COATED603
71335-2442-3FAMOTIDINE100 in 1 BOTTLETABLET, FILM COATED1003
71335-2442-4FAMOTIDINE90 in 1 BOTTLETABLET, FILM COATED903
71335-2442-5FAMOTIDINE15 in 1 BOTTLETABLET, FILM COATED153
71335-2442-6FAMOTIDINE120 in 1 BOTTLETABLET, FILM COATED1203
71335-2442-7FAMOTIDINE20 in 1 BOTTLETABLET, FILM COATED203
71335-2442-8FAMOTIDINE10 in 1 BOTTLETABLET, FILM COATED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2442FAMOTIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2Current NDC, 8 package rows20250402_7cef62ab-1740-4d0f-b6ea-fda783e1c197.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
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
ndc (product): 71335-2442
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 TabletPSN7cef62ab-1740-4d0f-b6ea-fda783e1c1973
284245famotidine 40 MG Oral TabletSCD7cef62ab-1740-4d0f-b6ea-fda783e1c1973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2442-17133524420130 TABLET, FILM COATED in 1 BOTTLE (71335-2442-1) 2024-07-15NoNoCurrent
71335-2442-27133524420260 TABLET, FILM COATED in 1 BOTTLE (71335-2442-2) 2024-07-15NoNoCurrent
71335-2442-371335244203100 TABLET, FILM COATED in 1 BOTTLE (71335-2442-3) 2024-07-15NoNoCurrent
71335-2442-47133524420490 TABLET, FILM COATED in 1 BOTTLE (71335-2442-4) 2024-07-15NoNoCurrent
71335-2442-57133524420515 TABLET, FILM COATED in 1 BOTTLE (71335-2442-5) 2024-07-15NoNoCurrent
71335-2442-671335244206120 TABLET, FILM COATED in 1 BOTTLE (71335-2442-6) 2024-07-15NoNoCurrent
71335-2442-77133524420720 TABLET, FILM COATED in 1 BOTTLE (71335-2442-7) 2024-07-15NoNoCurrent
71335-2442-87133524420810 TABLET, FILM COATED in 1 BOTTLE (71335-2442-8) 2024-07-15NoNoCurrent