FDA.reportPublic FDA data

Famotidine

Product NDC
72657-113
11-digit product format
726570113
Labeler code
72657
Product ID
72657-113_5502899d-30bd-4954-8aae-9ab1c034f65f
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
GLENMARK THERAPEUTICS INC., USA
Application
ANDA215822
Marketing category
ANDA
Marketing start
2022-06-01
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
A215822-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2022-01-28
A215822-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2022-01-28

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 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-286a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-281c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-281c564ffb4f44…

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199047Internal 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
95f51f27-d367-4cfd-a15f-7856c9e361fbAvailable 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
72657-113-20Famotidine1 in 1 CARTONTABLET, FILM COATED14
72657-113-20Famotidine200 in 1 BOTTLETABLET, FILM COATED2004
72657-113-88Famotidine85 in 1 BOTTLETABLET, FILM COATED854
72657-113-88Famotidine1 in 1 CARTONTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72657-113-20EA - Each72657-1136ddef29c-eb34-48e0-a98c-f7efee9fae4512026-03-17
72657-113-88EA - Each72657-113c41bab95-97f7-4d75-87b5-121b0fe8b76412026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72657-113FAMOTIDINE TABLET, FILM COATED [GLENMARK THERAPEUTICS INC., USA]3Current NDC, Legacy NDC, 4 package rows20250124_95f51f27-d367-4cfd-a15f-7856c9e361fb.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Curist Acid ReliefFAMOTIDINE 20 MGLittle Pharma, Inc.0fdfcc7c-aeed-6bd0-e063-6394a90ae52d2026-07-16WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINETWIN MED LLC795afb99-a3f4-4ffc-a905-2f84f3d86e4c2026-06-16WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINETWIN MED LLC6d97c60e-e39d-4541-ab49-d0fe3b3fa8402026-06-16WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
Acid Reducer Maximum StrengthFAMOTIDINE 20MGGrocery Outlet0c85b203-3d09-4799-97a9-722ee207bbfb2026-03-20WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEGLENMARK THERAPEUTICS INC., USA95f51f27-d367-4cfd-a15f-7856c9e361fb2026-01-13WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
ndc (product): 72657-113
FamotidineFAMOTIDINESAFEWAYf18c1195-48a1-69dc-e053-2a95a90a40772025-12-18WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
Heartburn ReliefFAMOTIDINEShield Pharmaceuticals Corp4e02a443-1e4c-46a5-8323-03d749b8634a2025-12-09WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
Welmate Famotidine 20mgFAMOTIDINE 20MGYYBA Corp1ea3c6b6-4c1e-d93c-e063-6394a90a0dac2025-07-29WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
Welmate Famotidine 10mgFAMOTIDINE 10MGYYBA Corp1e19d0cc-65d7-8ec4-e063-6394a90a3d2a2025-07-29WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEFAMILY DOLLAR99698eea-6bf1-42e8-9f48-d58fc04373242025-06-06WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEBi-Mart140440fb-d420-490d-8d7d-4b01c8ed3a832025-06-01WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEBi-Mart9974aa5e-e03f-4459-934a-ece27a8307462025-04-01WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEGeri-Care Pharmaceutical Corp288a8f87-e84a-a77a-e063-6294a90a86db2024-12-05WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEGERI-CARE PHARMACEUTICAL CORP287601b0-04ba-9611-e063-6394a90a91802024-12-04WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEVKT Pharma Private Limited1c2cfb3c-eaa0-403f-9589-d706afc06f512024-05-22WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEVKT Pharma Private Limited4e5db906-992f-476b-9d97-63a4c582bbdc2024-01-25WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
Acid ReducerFAMOTIDINEAllegiant Healthadc2721d-2ca7-4a47-bae1-be298fa1c1552024-01-16WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN95f51f27-d367-4cfd-a15f-7856c9e361fb4
310273famotidine 20 MG Oral TabletPSN95f51f27-d367-4cfd-a15f-7856c9e361fb4
199047famotidine 10 MG Oral TabletSCD95f51f27-d367-4cfd-a15f-7856c9e361fb4
310273famotidine 20 MG Oral TabletSCD95f51f27-d367-4cfd-a15f-7856c9e361fb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72657-113-20726570113201 BOTTLE in 1 CARTON (72657-113-20) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-06-010000-00-00NoNoCurrent
72657-113-88726570113881 BOTTLE in 1 CARTON (72657-113-88) / 85 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-06-010000-00-00NoNoCurrent