Signature Care Acid Controller

Product NDC
21130-777
11-digit product format
211300777
Labeler code
21130
Product ID
21130-777_9dfc87b3-cb54-427e-a28f-850117e8103b
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safeway
Application
ANDA077351
Marketing category
ANDA
Marketing start
2015-09-04
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
20 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21130-777DDiscontinued by firm2026-10-15
excluded packagepackage21130-77721130-777-02DDiscontinued by firm2026-10-15
excluded packagepackage21130-77721130-777-71DDiscontinued by firm2026-10-15
excluded packagepackage21130-77721130-777-82DDiscontinued by firm2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25c2088c7a36db…
2026-09-14 22:38:342026-08A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2584e616aacf4f…
2026-08-18 06:07:402026-07A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
21130-777-02Signature Care Acid Controllermaximum strength1 in 1 BLISTER PACKTABLET, FILM COATED15
21130-777-02Signature Care Acid Controllermaximum strength25 in 1 CARTONTABLET, FILM COATED255
21130-777-71Signature Care Acid Controllermaximum strength50 in 1 BOTTLETABLET, FILM COATED505
21130-777-71Signature Care Acid Controllermaximum strength1 in 1 CARTONTABLET, FILM COATED15
21130-777-82Signature Care Acid Controllermaximum strength1 in 1 CARTONTABLET, FILM COATED15
21130-777-82Signature Care Acid Controllermaximum strength200 in 1 BOTTLETABLET, FILM COATED2005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
TALCINACTIVE INGREDIENT7SEV7J4R1USIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-777SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [SAFEWAY]5Legacy NDC, 6 package rows20210722_ca5edcf8-1ed2-403a-a01b-0deb692bee0c.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 2 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Acid ReducerFAMOTIDINECardinal Health 110, LLC. dba Leader321b83f9-4bbf-494a-9279-80b0742049b62025-08-21WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
foster and thrive acid reducerFAMOTIDINEStrategic Sourcing Services LLC0c480ba4-b07e-4109-a9a9-5480b4a39a1d2025-08-21WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
members mark acid pepFAMOTIDINESam's West Incf9f4a91c-60a2-4893-88e6-639d242373752025-08-21WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
TopCare Acid ReducerFAMOTIDINETopco Associates LLCc3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe2025-08-15WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Rugby FamotidineFAMOTIDINERugby Laboratoriescdb6caa5-5be6-4597-a930-b8c816ac30402025-08-13WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid controllerFAMOTIDINESafewayf3d08f06-a676-43b0-8f77-611f0af737a72025-08-07WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
equate famotidineFAMOTIDINEWALMART INC.f38f8a8f-3292-4fe5-b83f-ffd634196d422025-07-16WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
FamotidineFAMOTIDINEPrecision Dose, Inc.de42b6c4-c44b-4ec1-b505-fc5266452d572025-05-27WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
acid reducerFAMOTIDINECVS Pharmacy373f5e28-e9e2-4af7-8a27-29b5d8f28b502025-04-07WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
heartburn reliefFAMOTIDINEMeijer Distribution Inc263ee489-fc3f-4578-b3a5-44f6d77578982025-02-13WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
kirkland signature acid controllerFAMOTIDINECostco Wholesale Companyd5d96078-ba87-4593-b15b-b7a646a8ab102025-02-12WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Acid ControllerFAMOTIDINEH E Bcbe72270-b172-4662-9b9b-557e8cf53ffe2025-02-11WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
basic care acid reducerFAMOTIDINEAmazon.com Services LLC0983cef7-b8b6-4ed9-a01e-c699fa6d2d062025-02-10WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
Major Heartburn Relief Maximum StrengthFAMOTIDINEMajor Pharmaceuticalsee0a263e-3f78-4534-9a30-803de636f92b2025-02-06WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
dg health heartburn preventionFAMOTIDINEDolgencorp Inc679cdecb-9e25-4f43-b4f4-7f5f3fbf22962024-11-11WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
topcare acid reducerFAMOTIDINETopco Associates LLC7824fdab-cdd5-457d-9b14-b82b19ea95292022-10-03WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
dg health acid reducerFAMOTIDINEDolgencorp Inc3ffa405e-bc85-4614-afd0-7a8dfc288dad2022-07-13WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
dg health heartburn preventionFAMOTIDINEDolgencorp Inca8383769-ce8b-43eb-b1a6-5d73e7fcf30d2022-06-07WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351
basic care acid reducerFAMOTIDINEAmazon.com Services LLC94fbcebe-7d75-47c1-9eca-cfa9b952a3d52022-01-06WarningsExact identifier
application applno (ANDA): 077351
application number: ANDA077351

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNca5edcf8-1ed2-403a-a01b-0deb692bee0c5
310273famotidine 20 MG Oral TabletSCDca5edcf8-1ed2-403a-a01b-0deb692bee0c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-777-022113007770225 BLISTER PACK in 1 CARTON (21130-777-02) > 1 TABLET, FILM COATED in 1 BLISTER PACK25 blister pack2015-09-060000-00-00NoNoCurrent
21130-777-71211300777711 BOTTLE in 1 CARTON (21130-777-71) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-040000-00-00NoNoCurrent
21130-777-82211300777821 BOTTLE in 1 CARTON (21130-777-82) > 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-040000-00-00NoNoCurrent