FAMOTIDINE

Product NDC
50090-6582
11-digit product format
500906582
Labeler code
50090
Product ID
50090-6582_19dcbba7-ac41-459f-9a13-3d9426f44f73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA215630
Marketing category
ANDA
Marketing start
2022-07-08
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 43.

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
A215630-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORALAB2022-01-07
A215630-002FAMOTIDINEFAMOTIDINE40MGTABLET / ORALAB2022-01-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A215630-001AB
A215630-002AB

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 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-0784e616aacf4f…
2026-09-14 22:38:342026-08A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-0784e616aacf4f…
2026-08-18 06:07:402026-07A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07caaa826d4ba7…
2026-08-18 06:07:402026-07A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-074b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215630-001FAMOTIDINE20MGTABLET / ORALAB2022-01-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A215630-002FAMOTIDINE40MGTABLET / ORALAB2022-01-07bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215630-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A215630-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A215630-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215630-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215630-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215630-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215630-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215630-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215630-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215630-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215630-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215630-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215630-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215630-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215630-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215630-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215630-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215630-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215630-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215630-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215630-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215630-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215630-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215630-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215630-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215630-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215630-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215630-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215630-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215630-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215630-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215630-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215630-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215630-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215630-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215630-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215630-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A215630-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215630-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A215630-002AB1bb7c543d1eb4…

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
FAMOTIDINE
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
3c32f8e2-f54a-422d-9c25-68692ea09001Available 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
50090-6582-0FAMOTIDINE30 in 1 BOTTLETABLET, FILM COATED303
50090-6582-1FAMOTIDINE20 in 1 BOTTLETABLET, FILM COATED203
50090-6582-2FAMOTIDINE60 in 1 BOTTLETABLET, FILM COATED603
50090-6582-3FAMOTIDINE90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6582-0EA - Each50090-6582d074af2b-b469-469c-8c3a-5836d13495ba12023-09-05
50090-6582-1EA - Each50090-658265c3cbfc-b9f0-4752-8f01-2ce05ea83df412023-09-05
50090-6582-2EA - Each50090-65826ff67819-a4e8-4ecd-a941-751e7973585112023-09-05
50090-6582-3EA - Each50090-6582538b8863-ffa5-4e25-ac45-2f32936c611212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6582FAMOTIDINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20230816_3c32f8e2-f54a-422d-9c25-68692ea09001.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.9c5dce17-1865-4aa6-89f6-24dd55b5f06c2026-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEPD-Rx Pharmaceuticals, Inc.a0f38398-4d34-4ecc-8a6a-37732adaaad32026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEHAWAII REPACK, INC.eec89230-47fc-4139-a370-b4f9e225e8c02026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.e59a2c97-19c7-485c-bb1b-272ddb9ae0532026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEA-S Medication Solutionse53928f3-5181-490b-acfb-be8d4cea60a92026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEA-S Medication Solutions05b47b1d-f7f3-4dae-9b22-d43d2a7cfaef2026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEST. MARY'S MEDICAL PARK PHARMACYfebe39b1-9212-a281-e053-6394a90a1a9f2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEPreferred Pharmaceuticals Inc.b445a613-eaa8-45e8-be1f-5848bfd1dd362026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEPreferred Pharmaceuticals Inc.dbf94314-3a34-4f03-80b1-296559b7d6a52026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.3ab235f4-da59-4a92-ad6b-c76cf3ecd9852026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEA-S Medication Solutions74a69baa-a7c5-4e67-8db6-2ec39ab6cfe52025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEBryant Ranch Prepack7cef62ab-1740-4d0f-b6ea-fda783e1c1972025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEA-S Medication Solutions3c32f8e2-f54a-422d-9c25-68692ea090012025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
ndc (product): 50090-6582
FAMOTIDINEFAMOTIDINEPD-Rx Pharmaceuticals, Inc.a3b50576-cd40-4f7e-9506-bd0a619884242025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEAscend Laboratories, LLCbe69d9f9-f4ad-4cfe-bab2-e07186b25c1e2025-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEBryant Ranch Prepacka24e8f45-6ace-4a81-8005-c23a55dadd9a2025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINENuCare Pharmceuticals,Inc.fc603d56-6828-8c5e-e053-6394a90a35bd2025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEBryant Ranch Prepack077bb160-e616-4863-bdde-989140f99e1c2024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINENuCare Pharmaceuticals,Inc.fd271deb-c748-bf26-e053-6294a90a11aa2024-06-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630
FAMOTIDINEFAMOTIDINEAsclemed USA, Inc.69bd5340-298b-46ca-83c7-0b5ef233f9c52024-04-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215630
application number: ANDA215630

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN3c32f8e2-f54a-422d-9c25-68692ea090013
310273famotidine 20 MG Oral TabletSCD3c32f8e2-f54a-422d-9c25-68692ea090013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6582-05009065820030 TABLET, FILM COATED in 1 BOTTLE (50090-6582-0) 2023-08-09NoNoCurrent
50090-6582-15009065820120 TABLET, FILM COATED in 1 BOTTLE (50090-6582-1) 2023-08-09NoNoCurrent
50090-6582-25009065820260 TABLET, FILM COATED in 1 BOTTLE (50090-6582-2) 2023-08-09NoNoCurrent
50090-6582-35009065820390 TABLET, FILM COATED in 1 BOTTLE (50090-6582-3) 2023-08-09NoNoCurrent