Ranitidine

Manufacturer
Liberty Pharmaceuticals, Inc.
Effective date
2013-09-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:39

Label at a glance#

ProductRanitidine
Active ingredientRANITIDINE HYDROCHLORIDE
Label structure9 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) do not chew tablet children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 150 mg (as ranitidine hydrochloride 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 certain foods and beverages

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • nausea or vomiting
  • stomach pain
  • unexplained weight loss
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, 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)
  • do not chew tablet
  • children under 12 years: ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • do not use if bottle seal is open or torn
  • store at 20° to 25°C (68° to 77°F)
  • protect from light
  • this product is sodium and sugar free

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, vanillin, red and yellow ferric oxide.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-706-5575 (Monday to Friday 8:30 a.m. – 5:00 p.m. Eastern Standard Time) 

Consumer Information

What you should know about

MAXIMUM STRENGTH 

Ranitidine Tablets USP, 150 mg / Acid Reducer 

(Please read all this information before taking MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg. Save this leaflet for future reference)

What are MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg?

MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg contains 150 mg of ranitidine (as ranitidine hydrochloride, 168 mg), a medicine that doctors have prescribed more than 200 million times  worldwide.

What symptoms do MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg treat and prevent?

MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieves and prevents heartburn associated with acid indigestion and sour stomach. 

Certain foods or beverages, and even lying down to sleep, can cause heartburn associated with acid indigestion and sour stomach. It is normal for the stomach to produce acid, especially after consuming food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can cause burning pain and discomfort.

ran-150mg-otc-esophagusran-150mg-otc-esophagus 

Excellent Safety Record

  • The ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg has been taken safely with many frequently prescribed medications.
  • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg are sodium and sugar free.

How should I take MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg?

  • 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.

This medicine can be used up to twice daily (do not take more than 2 tablets in 24 hours). 

MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg should not be given to children under 12 years old unless directed by a doctor.

How do MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg work?

MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg reduces the production of stomach acid. This is what makes MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.

Tips for managing heartburn

  • Do not lie flat or bend over soon after eating
  • Do not eat late at night, or just before bedtime
  • Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
  • Eat slowly and do not eat big meals
  • If you are overweight, lose weight
  • If you smoke, quit smoking
  • Raise the head of your bed
  • Wear loose fitting clothing around your stomach
  • Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

When should I see a doctor?

  • Do not use  
    • with other acid reducers
    • if you have kidney disease, except under the advice and supervision of a doctor 
    • 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. 
  • Ask a doctor before use if you have
    • nausea or vomiting
    • stomach pain
    • unexplained weight loss
    • frequent chest pain
    • frequent wheezing, particularly with heartburn
    • 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
  • Stop use and ask a doctor if
    • your heartburn continues or worsens
    • you need to take this product for more than 14 days
  • If pregnant or breast feeding, ask a health professional before use.
  • Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.

Questions or Comments?

Call 1-800-706-5575 (Monday to Friday, 8:30 am – 5:00 pm Eastern Standard Time) 

Manufactured by:                   Manufactured for:

Apotex Inc.                           Apotex Corp.

Toronto, Ontario                    Weston, FL

Canada M9L 1T9                   33326

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OTC Medicine

Maximum Strength

Rantidine Tablets USP, 150 mg

IMAGE LABEL
IMAGE LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198191ranitidine 150 MG Oral TabletPSN1
198191ranitidine 150 MG Oral TabletSCD1
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
RANITIDINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7f54af34-be54-4c3c-894f-78df6452d747Product name320190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850Product name520190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7bProduct name120180904
2f9d4e5c-e179-490e-8c43-f19e1e0ca228Product name120160720

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0440-2300-602020-01-31C16284748780-19d75b9d0-e12e-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-2300-60Ranitidine60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-2300RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20131204_14710d5d-16e8-48f8-9fd5-1530a087eb34.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-2300-60EA - Each0440-230014be2e14-2c7b-4460-94cc-12a8cc52385412014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHM1
RANITIDINEACTIVE MOIETY884KT10YB71
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IE1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
VANILLININACTIVE INGREDIENTCHI530446X1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0440-23000440-2300-60
60505-2880

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 · 253 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii candidate
28 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED, EXTENDED RELEASE / ORAL221 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOJELLY / TOPICALNAExact identifier — unii candidate
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675POWDER, FOR SUSPENSION / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675SUSPENSION, EXTENDED RELEASE / ORAL2.7 mgExact identifier — unii candidate
21 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
11 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, EXTENDED RELEASE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
VANILLINVANILLINCHI530446XSUSPENSION / ORAL6 mgExact identifier — unii candidate
15 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, DELAYED RELEASE / ORAL789.6 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE, FOR SUSPENSION / ORAL1.7 mgExact identifier — unii candidate
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UIMPLANT / INTRAVITREAL1.66 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii candidate
3 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, DELAYED RELEASE / ORAL366 mgExact identifier — unii candidate
28 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET, EXTENDED RELEASE / ORAL22 mgExact identifier — unii candidate
3 equally ranked IID candidates
VANILLINVANILLINCHI530446XSYRUP / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET, FILM COATED / ORAL18 mgExact identifier — unii candidate
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSYSTEM / TOPICAL54 mgExact identifier — unii candidate
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FOR SUSPENSION / ORAL20100 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZGUM, CHEWING / BUCCAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
VANILLINVANILLINCHI530446XTABLET, EXTENDED RELEASE / ORAL3.4 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 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
A200172-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31

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 22:38:342026-08A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-3184e616aacf4f…
2026-08-18 06:07:402026-07A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-313f01610625f2…
2019-09-15 20:21 UTC2019-09A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200172-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2012-05-31f41ea6bd6efb…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
96b79fbb-56cb-4338-8c37-3150d381782e14710d5d-16e8-48f8-9fd5-1530a087eb342013-09-24WarningsExact identifier
spl id: 96b79fbb-56cb-4338-8c37-3150d381782e
spl set id: 14710d5d-16e8-48f8-9fd5-1530a087eb34

Reported adverse events (FAERS/openFDA)#

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