Famotidine

Product NDC
51407-684
11-digit product format
514070684
Labeler code
51407
Product ID
51407-684_22941e23-59e9-f792-e063-6394a90a2552
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075805
Marketing category
ANDA
Marketing start
2001-04-16
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
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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1684e616aacf4f…
2026-09-14 22:38:342026-08A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1684e616aacf4f…
2026-08-18 06:07:402026-07A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16caaa826d4ba7…
2026-08-18 06:07:402026-07A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075805-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075805-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A075805-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075805-002AB1caaa826d4ba7…
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…

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
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
284245Internal RxNorm lookup
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
f67bcbc7-952c-61c0-e053-2a95a90a6fa6Available 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
51407-684-01Famotidine36 in 1 BOXTABLET363
51407-684-01Famotidine100 in 1 BOTTLETABLET1003
51407-684-10Famotidine24 in 1 BOXTABLET243
51407-684-10Famotidine1000 in 1 BOTTLETABLET10003
51407-684-18Famotidine36 in 1 BOXTABLET363
51407-684-18Famotidine180 in 1 BOTTLETABLET1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-684-01EA - Each51407-6848cae9de5-3e46-4dae-94c9-4f3cddfd7a2312023-04-07
51407-684-10EA - Each51407-6845ea42d27-91fe-439d-947f-06b7e834e47412023-04-07
51407-684-18EA - Each51407-684d264a1af-e005-4463-8f71-2152da7a1c1812023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-684FAMOTIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]3Current NDC, 6 package rows20241027_f67bcbc7-952c-61c0-e053-2a95a90a6fa6.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
ndc (product): 51407-684
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
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 TabletPSNf67bcbc7-952c-61c0-e053-2a95a90a6fa63
284245famotidine 40 MG Oral TabletPSNf67bcbc7-952c-61c0-e053-2a95a90a6fa63
310273famotidine 20 MG Oral TabletSCDf67bcbc7-952c-61c0-e053-2a95a90a6fa63
284245famotidine 40 MG Oral TabletSCDf67bcbc7-952c-61c0-e053-2a95a90a6fa63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-684-015140706840136 BOTTLE in 1 BOX (51407-684-01) / 100 TABLET in 1 BOTTLE36 bottle2023-03-08NoNoCurrent
51407-684-105140706841024 BOTTLE in 1 BOX (51407-684-10) / 1000 TABLET in 1 BOTTLE24 bottle2023-03-08NoNoCurrent
51407-684-185140706841836 BOTTLE in 1 BOX (51407-684-18) / 180 TABLET in 1 BOTTLE36 bottle2023-03-08NoNoCurrent