FDA.reportPublic FDA data

Ranitidine

Manufacturer
Target Corporation | Dr. Reddy's Laboratories Limited
Effective date
2019-09-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:22:32

Label at a glance#

ProductRanitidine
Active ingredientRanitidine Hydrochloride
Label structure11 sections

Dosage and administration

adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) children under 12 years: ask a doctor

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use(s)

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 foods and beverages

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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
  • if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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 doctor if

OTC - STOP USE SECTION

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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
    • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
    • can be used up to twice daily (do not take more than 2 tablets in 24 hours)
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • do not use if printed foil under bottle cap is open or torn
  • store at 20°-25°C (68°-77°F)
  • avoid excessive heat or humidity
  • protect from light
  • this product is sodium and sugar free

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

Call 1-888-375-3784

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

Bottle label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle


FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11673-849-402025-07-24C16284748780-12cef2736-6b4d-d83d-e063-dadaa90ab31fDrug Facts
11673-849-402025-01-30C16284748780-12cef2736-6b4d-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-849RANITIDINE TABLET, COATED [TARGET CORPORATION]2Legacy NDC20231103_6f9c004b-447a-dbd3-4108-338a9e87fff1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-404-34EA - Each55111-40477f8c9e5-f9d2-4d80-88c6-7059a252ae0612015-09-10

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-84911673-849-40
55111-404

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Ranitidine HydrochlorideBK76465IHMACTIM
FD&C RED NO. 40WZB9127XOAIACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
magnesium stearate70097M6I30IACT
cellulose, microcrystallineOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
titanium dioxide15FIX9V2JPIACT

Source Document#

Source XML

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
A078192-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31

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 22:38:342026-08A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3184e616aacf4f…
2026-08-18 06:07:402026-07A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-313f01610625f2…
2019-09-15 20:21 UTC2019-09A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31f41ea6bd6efb…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f1dbeeb2-3c68-4dc5-3ae5-d2f73db85e1c6f9c004b-447a-dbd3-4108-338a9e87fff12025-07-24WarningsExact identifier
spl set id: 6f9c004b-447a-dbd3-4108-338a9e87fff1
RanitidineRANITIDINEDr. Reddy's Laboratories Limited00df8a42-296f-80dd-98af-ee8b30eb38cc2025-05-23WarningsExact identifier
ndc (product): 55111-404

Reported adverse events (FAERS/openFDA)#

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