FDA.reportPublic FDA data

TopCare Acid Reducer

Product NDC
36800-141
11-digit product format
368000141
Labeler code
36800
Product ID
36800-141_c15b21b3-6e50-4ed4-90ef-28483e1cf535
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA075400
Marketing category
ANDA
Marketing start
2009-09-11
Substance
FAMOTIDINE
Active strength
10 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
A075400-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2005-03-18

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 UTC2026-02A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-183f01610625f2…
2019-09-15 20:21 UTC2019-09A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
TopCare Acid Reducer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE10 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
199047Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88722f84-dac8-4130-93b3-9e0dc1cc5accAvailable 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
36800-141-65TopCare Acid Reducer1 in 1 BLISTER PACKTABLET, FILM COATED19
36800-141-65TopCare Acid Reducer30 in 1 CARTONTABLET, FILM COATED309
36800-141-72TopCare Acid Reducer60 in 1 BOTTLETABLET, FILM COATED609
36800-141-72TopCare Acid Reducer1 in 1 CARTONTABLET, FILM COATED19
36800-141-75TopCare Acid Reducer1 in 1 CARTONTABLET, FILM COATED19
36800-141-75TopCare Acid Reducer90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-141-65EA - Each36800-14124ce8558-cf62-4c41-a9d2-70cb21ee9db312012-07-24
36800-141-72EA - Each36800-141b5decd5c-872e-4c8c-b713-bfbc49abbff812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8TOPCARE ACID REDUCER (FAMOTIDINE) TABLET [TOPCO ASSOCIATES LLC]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8TOPCARE ACID REDUCER (FAMOTIDINE) TABLET [TOPCO ASSOCIATES LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPCARE ACID REDUCER (FAMOTIDINE) TABLET [TOPCO ASSOCIATES LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPCARE ACID REDUCER (FAMOTIDINE) TABLET [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-141TOPCARE ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 6 package rows20250214_88722f84-dac8-4130-93b3-9e0dc1cc5acc.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Acid ReliefFAMOTIDINEAmerican Sales Companyed474c9d-c08b-4f52-8b24-5887978e42752026-07-01WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
acid reliefFAMOTIDINERite Aid Corporation9826dd26-5592-4f96-9274-005ef9462cb42026-05-27WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
good sense acid reducerFAMOTIDINEL. Perrigo Companycc77f6ff-a534-4731-b971-4912808408992026-05-18WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
acid reducer original strengthFAMOTIDINEHyVee Inca0f2683f-59ad-4f65-a108-696430d577ab2026-03-16WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
Acid Controller Original StrengthFAMOTIDINEWalgreen Company98c6ddc9-8103-40b3-a145-ffbe3374ab6c2026-03-03WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
heartburn relief original strengthFAMOTIDINEMajor Pharmaceuticalsbe275c48-18bf-45f6-891d-36d89327813e2026-02-13WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
ACID CONTROLLERFAMOTIDINESafeway9ddfb9fd-1b84-4e9a-90b5-6a3362d345dd2025-08-13WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
acid controllerFAMOTIDINEH E B813d742f-8f3d-4f18-a6c5-03eea946f9762025-06-23WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
TopCare Acid ReducerFAMOTIDINETopco Associates LLC88722f84-dac8-4130-93b3-9e0dc1cc5acc2025-06-13WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
ndc (product): 36800-141
heartburn reliefFAMOTIDINEMeijer Distribution Inc05c03fd8-abc8-47f7-868c-895b9a38c5b32025-02-17WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
acid reducerFAMOTIDINEPublix Super Markets Inca3ba9983-6747-45b2-b270-4ac1fb9d6e402025-02-17WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
acid controller original strengthFAMOTIDINECVS Pharmacyc7cb4e19-3442-45d2-b60a-87d4beea862a2025-02-13WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
dg health heartburn prevention original strengthFAMOTIDINEDolgencorp, LLCf5c0ff75-77da-443c-a510-9c6a065ddc6c2025-02-11WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
foster and thrive acid reducerFAMOTIDINEStrategic Sourcing Services LLC9ff8539f-cdcd-4823-8baa-10a249c9220d2025-02-10WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
basic care acid reducerFAMOTIDINEAmazon.com Services LLC52e3b2f5-f3b9-4f4e-a70f-322eb04e6e8a2025-02-10WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
signature care acid controllerFAMOTIDINESafewayadbf2c58-cd1c-4444-b133-21a18a3489312025-02-10WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
equaline heartburn preventionFAMOTIDINEUnited Natural Foods, Inc. dba UNFI4b78d0c8-7d0c-45e6-9b36-b248f002f2b82025-02-10WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
Equate FamotidineFAMOTIDINEWal-Mart Stores Inc15973213-0e11-4d18-b437-50b0a593cb7b2025-02-06WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
heartburn relief original strengthFAMOTIDINEProficient Rx LP5567aaaf-b4f2-4604-b841-c9447e77256c2019-10-01WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN88722f84-dac8-4130-93b3-9e0dc1cc5acc9
199047famotidine 10 MG Oral TabletSCD88722f84-dac8-4130-93b3-9e0dc1cc5acc9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-141-653680001416530 BLISTER PACK in 1 CARTON (36800-141-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2009-10-130000-00-00NoNoCurrent
36800-141-72368000141721 BOTTLE in 1 CARTON (36800-141-72) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-09-110000-00-00NoNoCurrent
36800-141-75368000141751 BOTTLE in 1 CARTON (36800-141-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-03-220000-00-00NoNoCurrent