Famotidine

Product NDC
71335-1520
11-digit product format
713351520
Labeler code
71335
Product ID
71335-1520_fd9976bd-f0c4-4e3a-b38b-2674f6e73c80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075805
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
2026-12-31
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
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…

Additional Listing Data#

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

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
3031c7d1-5a4e-42b3-a3ca-9ac2ea2f76fbAvailable 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
71335-1520-1Famotidine30 in 1 BOTTLETABLET306
71335-1520-2Famotidine60 in 1 BOTTLETABLET606
71335-1520-3Famotidine20 in 1 BOTTLETABLET206
71335-1520-4Famotidine90 in 1 BOTTLETABLET906
71335-1520-5Famotidine100 in 1 BOTTLETABLET1006
71335-1520-6Famotidine10 in 1 BOTTLETABLET106
71335-1520-7Famotidine120 in 1 BOTTLETABLET1206
71335-1520-8Famotidine50 in 1 BOTTLETABLET506
71335-1520-9Famotidine14 in 1 BOTTLETABLET146

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1520-2EA - Each71335-1520cedbb65d-2176-4eaa-9f6b-6b09e31fd67512023-01-09
71335-1520-3EA - Each71335-15200c436d97-5071-4ad1-8d2f-5244125b239f12023-01-09
71335-1520-4EA - Each71335-15207e8a8b01-96b4-4f84-a33a-819f202454fd12023-01-09
71335-1520-5EA - Each71335-152071eca099-f0cf-4a8c-91fa-0221eb9d15d012023-01-09
71335-1520-6EA - Each71335-15206520bacb-527d-43bf-ba9a-92455a8adec512023-01-09
71335-1520-7EA - Each71335-1520b4f4488d-d375-400e-afb3-eb6dde0ff62e12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1520FAMOTIDINE TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 9 package rows20240915_3031c7d1-5a4e-42b3-a3ca-9ac2ea2f76fb.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
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
ndc (product): 71335-1520
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 TabletPSN3031c7d1-5a4e-42b3-a3ca-9ac2ea2f76fb6
310273famotidine 20 MG Oral TabletSCD3031c7d1-5a4e-42b3-a3ca-9ac2ea2f76fb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1520-17133515200130 TABLET in 1 BOTTLE (71335-1520-1) 30 tablet2020-02-200000-00-00NoNoCurrent
71335-1520-27133515200260 TABLET in 1 BOTTLE (71335-1520-2) 60 tablet2021-03-300000-00-00NoNoCurrent
71335-1520-37133515200320 TABLET in 1 BOTTLE (71335-1520-3) 20 tablet2022-07-140000-00-00NoNoCurrent
71335-1520-47133515200490 TABLET in 1 BOTTLE (71335-1520-4) 90 tablet2022-02-150000-00-00NoNoCurrent
71335-1520-571335152005100 TABLET in 1 BOTTLE (71335-1520-5) 100 tablet2024-09-060000-00-00NoNoCurrent
71335-1520-67133515200610 TABLET in 1 BOTTLE (71335-1520-6) 10 tablet2021-06-290000-00-00NoNoCurrent
71335-1520-771335152007120 TABLET in 1 BOTTLE (71335-1520-7) 120 tablet2021-10-070000-00-00NoNoCurrent
71335-1520-87133515200850 TABLET in 1 BOTTLE (71335-1520-8) 50 tablet2024-09-060000-00-00NoNoCurrent
71335-1520-97133515200914 TABLET in 1 BOTTLE (71335-1520-9) 14 tablet2024-09-06NoNoCurrent