Acid Reducer

Product NDC
53942-443
Requested package NDC
53942-443-25
11-digit product format
539420443
Labeler code
53942
Product ID
53942-443_b53bbe14-3a58-4212-8f9d-46be5f48fdc6
Type
HUMAN OTC DRUG
Nonproprietary name
Acid Reducer
Dosage form
TABLET
Route
ORAL
Labeler
Demoulas Super Markets, Inc.
Application
ANDA215822
Marketing category
ANDA
Marketing start
2023-11-30
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 45.

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 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-11-14 07:37:172026-10A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28d4dbc9d85df4…
2026-11-14 07:37:172026-10A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28d4dbc9d85df4…
2026-10-15 13:18:302026-09A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28c2088c7a36db…
2026-10-15 13:18:302026-09A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28c2088c7a36db…
2026-09-14 22:38:342026-08A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2884e616aacf4f…
2026-09-14 22:38:342026-08A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2884e616aacf4f…
2026-08-18 06:07:402026-07A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28caaa826d4ba7…
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…

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
Acid Reducer
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
63b6012e-0221-48ab-a142-2d302ed6476aAvailable on FDA.report

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 · 16 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
FamotidineFAMOTIDINESAFEWAYf18c1195-48a1-69dc-e053-2a95a90a40772025-12-18WarningsExact 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53942-443-25539420443251 BOTTLE in 1 CARTON (53942-443-25) / 25 TABLET in 1 BOTTLE1 bottle2023-11-30NoNoCurrent