Famotidine Tablets USP, 10 mg

Manufacturer
Wockhardt USA LLC. | Wockhardt Limited
Effective date
2019-11-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:57:32

Label at a glance#

ProductFAMOTIDINE
Active ingredientFAMOTIDINE
Label structure10 sections

Indications and uses

relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Dosage and administration

●  adults and children 12 years and over:     ● to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.     ● to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn     ● do not use more than 2 tablets in 24 hours     ● children under 12 years: ask a doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Famotidine USP 10 mg

OTC - PURPOSE SECTION

Acid reducer

USES

INDICATIONS & USAGE SECTION

  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

WARNINGS

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

DO NOT USE

●   if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.    

●   with other acid reducers

ASK A DOCTOR BEFORE USE IF YOU HAVE

●   had heartburn over 3 months. This may be a sign of a more serious condition.

●   heartburn with lightheadedness, sweating or dizziness 

●   chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

●   frequent chest pain 

●   frequent wheezing, particularly with heartburn

●   unexplained weight loss     

●   nausea or vomiting

●   stomach pain

Stop use and ask a doctor if

●   your heartburn continues or worsens

●   you need to take this product for more than 14 days

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

●  adults and children 12 years and over:

    ● to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

    ● to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn

    ● do not use more than 2 tablets in 24 hours

    ● children under 12 years: ask a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

●  read the directions and warnings before use

●  store at 25°-30°C (77°-86°F)

●  protect from moisture

●  keep the carton and package insert. They contain important information.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide.

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

Call 1-800-346-6854

SPL UNCLASSIFIED SECTION

Manufactured by:

Wockhardt Limited,

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Iss.100510

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Famotidine Tablets USP, 10 mg (OTC)

10 mg – Acid reducer

64679-972-03

Label
Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z81
FAMOTIDINEACTIVE MOIETY5QZO15J2Z81
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K141
HYPROMELLOSE 2910 (6 CPS)INACTIVE INGREDIENT0WZ8WG20P61
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64679-97264679-972-01, 64679-972-02, 64679-972-00, 64679-972-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 241 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TALCTALC7SEV7J4R1UELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION/ DROPS / ORAL90 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
28 equally ranked IID candidates
HYPROMELLOSE 2910 (6 CPS)HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6TABLET / ORAL880 mgExact identifier — unii candidate
16 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / BUCCAL15 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / SUBLINGUAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED / ORAL87 mgExact identifier — unii candidate
35 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE2165RE0K14TABLET, DELAYED RELEASE / ORAL103 mgExact identifier — unii candidate
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / RECTAL0.25 mg/mgExact identifier — unii candidate
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1576 mgExact identifier — unii candidate
28 equally ranked IID candidates
HYPROMELLOSE 2910 (6 CPS)HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6POWDER, FOR SUSPENSION / ORAL504 mgExact identifier — unii candidate
16 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii candidate
36 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, EXTENDED RELEASE / ORAL184 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCREAM / TOPICAL10 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, EXTENDED RELEASE / ORAL194 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSWAB / TOPICAL5250 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUSPENSION / ORAL400 mgExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSE 2910 (6 CPS)HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6TABLET, DELAYED RELEASE / ORAL77 mgExact identifier — unii candidate
16 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE PARTICLES / ORAL580 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii candidate
28 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, DELAYED RELEASE / ORAL366 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQLOTION / TOPICAL5 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
HYPROMELLOSE 2910 (6 CPS)HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6TABLET, EXTENDED RELEASE / ORAL85 mgExact identifier — unii candidate
16 equally ranked IID candidates
HYPROMELLOSE 2910 (6 CPS)HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6CAPSULE / ORAL600 mgExact identifier — unii candidate
16 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAVENOUS28216 mgExact identifier — unii candidate
36 equally ranked IID candidates
HYPROMELLOSE 2910 (6 CPS)HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6TABLET, FILM COATED, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
16 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077146-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2005-03-07

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-0784e616aacf4f…
2026-08-18 06:07:402026-07A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-073f01610625f2…
2019-09-15 20:21 UTC2019-09A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07f41ea6bd6efb…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
26d8f047-874e-844d-e063-6394a90ab7eefe1b437a-07de-4d5a-aa95-955e849dc6d62024-11-13WarningsExact identifier
spl set id: fe1b437a-07de-4d5a-aa95-955e849dc6d6

Reported adverse events (FAERS/openFDA)#

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