Famotidine

Product NDC
71335-1950
11-digit product format
713351950
Labeler code
71335
Product ID
71335-1950_6e3954f4-f887-4ead-9790-c5262ccf5307
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075718
Marketing category
ANDA
Marketing start
2001-04-16
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
2027-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 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
310273Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
545d5c1f-ec1c-4135-965f-333ad888d96fAvailable 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
71335-1950-0Famotidine40 in 1 BOTTLETABLET, FILM COATED40102
71335-1950-1Famotidine30 in 1 BOTTLETABLET, FILM COATED30102
71335-1950-2Famotidine60 in 1 BOTTLETABLET, FILM COATED60102
71335-1950-3Famotidine20 in 1 BOTTLETABLET, FILM COATED20102
71335-1950-4Famotidine90 in 1 BOTTLETABLET, FILM COATED90102
71335-1950-5Famotidine100 in 1 BOTTLETABLET, FILM COATED100102
71335-1950-6Famotidine10 in 1 BOTTLETABLET, FILM COATED10102
71335-1950-7Famotidine120 in 1 BOTTLETABLET, FILM COATED120102
71335-1950-8Famotidine50 in 1 BOTTLETABLET, FILM COATED50102
71335-1950-9Famotidine14 in 1 BOTTLETABLET, FILM COATED14102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1950-0EA - Each71335-19506663d7de-f462-48b5-8038-bfe0b17b2c6512026-04-20
71335-1950-1EA - Each71335-1950fe791c10-7c08-45a3-a0f8-ba1cc4872ca012026-04-20
71335-1950-2EA - Each71335-1950a7c01c76-8c97-4ab3-bcb1-c41195699c5412026-04-20
71335-1950-3EA - Each71335-1950b655b373-4f12-45ec-81e5-0ad3b44e399812026-04-20
71335-1950-4EA - Each71335-195037f963f6-cc39-4bfd-ac17-cebc4b45ab8012026-04-20
71335-1950-5EA - Each71335-1950fa48d20a-79ae-4f1e-90b3-38e9194a662112026-04-20
71335-1950-6EA - Each71335-195009044c4f-2267-4f37-86c2-6046e7afa71012026-04-20
71335-1950-7EA - Each71335-1950772b8031-f4ad-46f2-9110-432c70a040cd12026-04-20
71335-1950-8EA - Each71335-1950cb23ba6f-ffee-4ddb-87c2-3433d1d1bc4c12026-04-20
71335-1950-9EA - Each71335-1950851a2b6e-ba70-4784-a6a5-e22907b08ec812026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1950FAMOTIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 10 package rows20231201_545d5c1f-ec1c-4135-965f-333ad888d96f.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
ndc (product): 71335-1950
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 TabletPSN545d5c1f-ec1c-4135-965f-333ad888d96f102
310273famotidine 20 MG Oral TabletSCD545d5c1f-ec1c-4135-965f-333ad888d96f102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1950-07133519500040 TABLET, FILM COATED in 1 BOTTLE (71335-1950-0) 2026-03-31NoNoCurrent
71335-1950-17133519500130 TABLET, FILM COATED in 1 BOTTLE (71335-1950-1) 2026-03-310000-00-00NoNoCurrent
71335-1950-27133519500260 TABLET, FILM COATED in 1 BOTTLE (71335-1950-2) 2026-03-310000-00-00NoNoCurrent
71335-1950-37133519500320 TABLET, FILM COATED in 1 BOTTLE (71335-1950-3) 2026-03-310000-00-00NoNoCurrent
71335-1950-47133519500490 TABLET, FILM COATED in 1 BOTTLE (71335-1950-4) 2026-03-310000-00-00NoNoCurrent
71335-1950-571335195005100 TABLET, FILM COATED in 1 BOTTLE (71335-1950-5) 2026-03-310000-00-00NoNoCurrent
71335-1950-67133519500610 TABLET, FILM COATED in 1 BOTTLE (71335-1950-6) 2026-03-310000-00-00NoNoCurrent
71335-1950-771335195007120 TABLET, FILM COATED in 1 BOTTLE (71335-1950-7) 2026-03-310000-00-00NoNoCurrent
71335-1950-87133519500850 TABLET, FILM COATED in 1 BOTTLE (71335-1950-8) 2026-03-310000-00-00NoNoCurrent
71335-1950-97133519500914 TABLET, FILM COATED in 1 BOTTLE (71335-1950-9) 2026-03-31NoNoCurrent