heartburn relief

Product NDC
41250-712
11-digit product format
412500712
Labeler code
41250
Product ID
41250-712_889e4edf-e58d-4fa4-8ed1-5b4eab8c8e49
Type
HUMAN OTC DRUG
Nonproprietary name
famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA077351
Marketing category
ANDA
Marketing start
2019-04-17
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077351-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2006-09-25

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-253f01610625f2…
2019-09-15 20:21 UTC2019-09A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
heartburn relief
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
263ee489-fc3f-4578-b3a5-44f6d7757898Available 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
41250-712-02heartburn relief25 in 1 CARTONTABLET, FILM COATED257
41250-712-02heartburn relief1 in 1 BLISTER PACKTABLET, FILM COATED17
41250-712-71heartburn relief50 in 1 BOTTLETABLET, FILM COATED507
41250-712-71heartburn relief1 in 1 CARTONTABLET, FILM COATED17
41250-712-78heartburn relief2 in 1 CARTONTABLET, FILM COATED27
41250-712-78heartburn relief50 in 1 BOTTLETABLET, FILM COATED507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-712HEARTBURN RELIEF (FAMOTIDINE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]7Current NDC, Legacy NDC, 6 package rows20250215_263ee489-fc3f-4578-b3a5-44f6d7757898.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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Acid Controller maximum strengthFAMOTIDINESafewayca5edcf8-1ed2-403a-a01b-0deb692bee0c2026-06-30WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid reliefFAMOTIDINERite Aid Corporation8c6d5419-088b-4b3e-80b8-2a0d06926ff12026-06-03WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
ACID REDUCERFAMOTIDINEHyVee Inc381db08e-5756-4255-8202-1d8e6a1cf0382026-06-03WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid reliefFAMOTIDINERite Aid Corporation34034d16-dc3b-436d-8ec8-84b3c1f8e48a2026-06-03WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
CareOne Acid ReliefFAMOTIDINEAmerican Sales Company206f5483-7de1-4bc3-af27-190e211bcb952026-05-21WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
ACID REDUCERFAMOTIDINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf347f870-1da4-4a77-8c20-63b703d240712026-05-13WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Good Sense Acid ReducerFAMOTIDINEL. Perrigo Company39cb0f15-d177-46eb-a549-7acb885fbf072026-05-11WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Acid ControllerFAMOTIDINEWalgreen Company42392cb1-7958-4a2f-8622-f00f02afd9612026-04-24WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid controllerFAMOTIDINECVS Pharmacy1531aa51-02e9-45ed-99aa-53b21732dd2e2026-04-06WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Rolaids ACID DEFENSEFAMOTITINEThe Procter & Gamble Manufacturing Company3bdbeabb-6b06-5468-e063-6394a90a03c92026-03-30WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
ACID REDUCERFAMOTIDINEPublix Super Markets Inc3455be3c-696e-402a-a5df-830544fa525a2026-03-11WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Equate FamotidineFAMOTIDINEWal-Mart Stores Inc8ac94821-aa78-4e57-bc9a-f1f2a0e47b072026-03-03WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid controllerFAMOTIDINEWalgreen Companyc16d9977-39ad-4386-8867-72aab97c99d52026-02-28WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
berkley and jensen famotidineFAMOTIDINEBJWC93c857e4-72b3-433e-ae6f-281cd57e39962026-02-17WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid reducerFAMOTIDINEH E B140f0e60-c809-4d86-a750-7649ee2881b52026-02-03WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid reliefFAMOTIDINERite Aid Corporation45789b7a-e9c7-4813-b07b-f88d9108455d2026-01-06WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
careone acid reliefFAMOTIDINERetail Business Services, LLC8f654234-b25d-47d6-b1f8-f7f3535697952025-10-30WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Acid ControllerFAMOTIDINEH E B8aac5a0d-074b-4cf4-ab10-549e1ed09e2f2025-10-30WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
equaline heartburn preventionFAMOTIDINEUnited Natural Foods, Inc. dba UNFIf40f1dcf-249a-4ccb-bdfc-acff49dd4a152025-09-25WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
basic care heartburn preventionFAMOTIDINEAmazon.com Services LLC8d57f6db-a9f0-4416-9f49-17ce3571b0aa2025-09-04WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN263ee489-fc3f-4578-b3a5-44f6d77578987
310273famotidine 20 MG Oral TabletSCD263ee489-fc3f-4578-b3a5-44f6d77578987

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-712-024125007120225 BLISTER PACK in 1 CARTON (41250-712-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK25 blister pack2019-04-170000-00-00NoNoCurrent
41250-712-71412500712711 BOTTLE in 1 CARTON (41250-712-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-04-170000-00-00NoNoCurrent
41250-712-78412500712782 BOTTLE in 1 CARTON (41250-712-78) / 50 TABLET, FILM COATED in 1 BOTTLE2 bottle2022-08-110000-00-00NoNoCurrent