Famotidine

Product NDC
31722-017
11-digit product format
317220017
Labeler code
31722
Product ID
31722-017_d1215804-20c7-e3f3-e053-2a95a90aa13b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA215767
Marketing category
ANDA
Marketing start
2021-11-04
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
A215767-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORALAB2021-11-04
A215767-002FAMOTIDINEFAMOTIDINE40MGTABLET / ORALAB2021-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215767-001AB
A215767-002AB

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 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-044b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-04782e0a99824c…
2021-12-28 21:50 UTC2021-12A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-04782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215767-001FAMOTIDINE20MGTABLET / ORALAB2021-11-046a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215767-002FAMOTIDINE40MGTABLET / ORALAB2021-11-046a51e52b5d6a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215767-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215767-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215767-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215767-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215767-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215767-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215767-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215767-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215767-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215767-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215767-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215767-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215767-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215767-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215767-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215767-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215767-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215767-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215767-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215767-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215767-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215767-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215767-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215767-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215767-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215767-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215767-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215767-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215767-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215767-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215767-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215767-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215767-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A215767-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215767-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A215767-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A215767-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A215767-002AB1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215767-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215767-002AB16a51e52b5d6a…

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 · 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
902b5d4b-1707-4312-9f46-ef5ab86b00f0Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-017-01Famotidine100 in 1 BOTTLETABLET, FILM COATED1001
31722-017-10Famotidine1000 in 1 BOTTLETABLET, FILM COATED10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-017-01EA - Each31722-017aa2d418a-65f4-4629-b45a-545f33d8bf8212022-03-09
31722-017-10EA - Each31722-017de293d74-1a22-4abd-b61d-f483b31a130212022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-017FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 2 package rows20211121_902b5d4b-1707-4312-9f46-ef5ab86b00f0.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINERedpharm Drug55730918-d9e8-eaad-e063-6394a90aeda22026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
FamotidineFAMOTIDINEST. MARY'S MEDICAL PARK PHARMACY31cdc900-fe17-2d5f-e063-6294a90a0fda2026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
FamotidineFAMOTIDINEPreferred Pharmaceuticals, Inc.b1edf3c5-e42c-471b-8771-6c93094822de2026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.002875d2-8c30-2d2e-e063-6294a90ae01e2025-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.2f5ec69d-926c-47a2-be47-8fef2e0ff2072025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
FamotidineFAMOTIDINEBryant Ranch Prepacke034546b-28cb-41aa-9441-655cdb9665542025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
FamotidineFAMOTIDINENuCare Pharmaceuticals, Inc.2cdd1a75-5d68-7f9d-e063-6294a90aeee32025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
FamotidineFAMOTIDINEAdvanced Rx Pharmacy of Tennessee, LLCfa18ed52-f038-02dd-e053-6394a90ac9462024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
Acid ReducerFAMOTIDINEAllegiant Health5c6c6665-cb0a-41d1-af28-85b4f061bd1b2024-10-30WarningsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
FamotidineFAMOTIDINEA-S Medication Solutions66878006-8913-4c91-8038-901142cf520d2024-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
FamotidineFAMOTIDINEA-S Medication Solutions0abfc8e6-7fdf-4828-89f4-2202002f84892024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
FamotidineFAMOTIDINEA-S Medication Solutions75a334ee-48b9-47e7-8225-6e595bed8a742024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
FamotidineFAMOTIDINEA-S Medication Solutions99de67a5-a566-46c9-bc80-dc6fc03be11f2023-11-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
FamotidineFAMOTIDINECamber Pharmaceuticals, Inc.902b5d4b-1707-4312-9f46-ef5ab86b00f02021-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215767
application number: ANDA215767
ndc (product): 31722-017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN002875d2-8c30-2d2e-e063-6294a90ae01e9
310273famotidine 20 MG Oral TabletSCD002875d2-8c30-2d2e-e063-6294a90ae01e9
310273famotidine 20 MG Oral TabletPSN2cdd1a75-5d68-7f9d-e063-6294a90aeee32
310273famotidine 20 MG Oral TabletPSNfa18ed52-f038-02dd-e053-6394a90ac9462
310273famotidine 20 MG Oral TabletSCD2cdd1a75-5d68-7f9d-e063-6294a90aeee32
310273famotidine 20 MG Oral TabletSCDfa18ed52-f038-02dd-e053-6394a90ac9462
310273famotidine 20 MG Oral TabletPSN0abfc8e6-7fdf-4828-89f4-2202002f84891
310273famotidine 20 MG Oral TabletPSN75a334ee-48b9-47e7-8225-6e595bed8a741
310273famotidine 20 MG Oral TabletPSN902b5d4b-1707-4312-9f46-ef5ab86b00f01
284245famotidine 40 MG Oral TabletPSN902b5d4b-1707-4312-9f46-ef5ab86b00f01
310273famotidine 20 MG Oral TabletSCD0abfc8e6-7fdf-4828-89f4-2202002f84891
310273famotidine 20 MG Oral TabletSCD75a334ee-48b9-47e7-8225-6e595bed8a741
310273famotidine 20 MG Oral TabletSCD902b5d4b-1707-4312-9f46-ef5ab86b00f01
284245famotidine 40 MG Oral TabletSCD902b5d4b-1707-4312-9f46-ef5ab86b00f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-017-0131722001701100 TABLET, FILM COATED in 1 BOTTLE (31722-017-01) 2021-11-040000-00-00NoNoCurrent
31722-017-10317220017101000 TABLET, FILM COATED in 1 BOTTLE (31722-017-10) 2021-11-040000-00-00NoNoCurrent