Omeprazole Magnesium

Manufacturer
Dr. Reddy's Laboratories Limited | Nutra-Med Packaging LLC | Dr. Reddy's Laboratories Limited (FTO-SEZ PU 1)
Effective date
2025-05-28
Label type
HUMAN OTC DRUG LABEL
Version
22
Source
full-release
Hydrated at
2026-06-01 01:01:39

Label at a glance#

ProductOmeprazole Magnesium
Active ingredientOMEPRAZOLE MAGNESIUM
Label structure12 sections

Dosage and administration

• for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours     14- Day Course of Treatment   • swallow 1 capsule with a glass of water before eating in the morning   • take every day for 14 days   • do not take more than 1 capsule a day   • do not use fo...

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

*Omeprazole delayed-release capsules 20 mg (equivalent to 20.6 mg omeprazole magnesium)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use

INDICATIONS & USAGE SECTION

• treats frequent heartburn (occurs 2 or more days a week)

• not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

WARNINGS SECTION

Allergy alert:

  • Do not use if you are allergic to omeprazole
  • Omeprazole may cause severe skin reactions. Symptoms may include:
    • skin reddening
    • blisters
    • rash
    If an allergic reaction occurs, stop use and seek medical help right away.

Do not use if you have:

OTC - DO NOT USE SECTION

  • trouble or pain swallowing food, vomiting with blood, or bloody or black stools
  • 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

These may be signs of a serious condition. See your 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.
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug.

Acid reducers may interact with certain prescription drugs.

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
  • you need to take more than 1 course of treatment every 4 months
  • you get diarrhea
  • you develop a rash or joint pain

 

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

• for adults 18 years of age and older

• this product is to be used once a day (every 24 hours), every day for 14 days

• it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 

  14- Day Course of Treatment

  • swallow 1 capsule with a glass of water before eating in the morning

  • take every day for 14 days

  • do not take more than 1 capsule a day

  • do not use for more than 14 days unless directed by your doctor

  • swallow whole. Do not chew or crush capsules.

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months

  • do not take for more than 14 days or more often than every 4 months unless directed by a doctor

• children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

Other information

SPL UNCLASSIFIED SECTION

• read the directions and warnings before use 

• keep the carton. It contains important information. 

• store at 20 – 25°C (68 –77°F) and protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions

OTC - QUESTIONS SECTION

call 1-888-375-3784

Tips for Managing Heartburn

SPL UNCLASSIFIED SECTION

  • Do not lie flat or bend over after eating
  • Do not wear tight-fitting clothing around the stomach
  • Do not eat before bedtime
  • Raise the head of your bed
  • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
  • Eat slowly and avoid big meals
  • If overweight, lose weight
  • Quit smoking

Revised: 10/2022

Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr.Reddy's

NDC 55111-397-52

Treats Frequent Heartburn! 24 HR

Omeprazole

Delayed Release- Capsules

20 mg*

ACID REDUCER

14 Capsules(Safety Sealed)

One 14-Day Course of Treatment

May take 1 to 4 days for full effect

BottleBottle

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr.Reddy's

NDC 55111-397-52

Compare to the active ingredient in Prilosec OTC® **

Treats Frequent Heartburn! 24 HR

Omeprazole

Delayed Release- Capsules

20 mg*

ACID REDUCER

14 Capsules(Safety Sealed)

One 14-Day Course of Treatment

May take 1 to 4 days for full effect

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN22
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD22
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY22

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-397-27EA - Each55111-397cb783e2e-a92f-4544-908b-095fd6075f3f12015-09-10
55111-397-28EA - Each55111-3973a546396-9702-499f-8c97-c73cf8ec977a12012-07-24
55111-397-33EA - Each55111-39758ac9e87-c988-410b-b086-0aa500956a4912015-09-10
55111-397-42EA - Each55111-397fbe87769-c688-436e-bf0c-6659b849179b12012-07-24
55111-397-52EA - Each55111-39703066f2b-a765-4b49-a5d7-503ff8fffe0712013-03-03
55111-397-74EA - Each55111-397518a761d-8d23-42b2-9c1d-fa2a0f56621112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OMEPRAZOLE MAGNESIUMACTIVE INGREDIENT426QFE7XLK9
omeprazoleACTIVE MOIETYKG60484QX99
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92J9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6759
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3579
GELATININACTIVE INGREDIENT2G86QN327L9
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE49
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBU9
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71G9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I309
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8J9
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S25779
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H9
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V39
RAW SUGARINACTIVE INGREDIENT8M707QY5GH9
SHELLACINACTIVE INGREDIENT46N107B71O9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU49
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J9
TALCINACTIVE INGREDIENT7SEV7J4R1U9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP9
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UM9

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55111-39755111-397-52, 55111-397-27, 55111-397-33, 55111-397-39, 55111-397-74, 55111-397-28, 55111-397-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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 4 · 232 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
HYPROMELLOSE 2208 (3 MPA.S)HYPROMELLOSE 2208 (3 MPA.S)9H4L916OBUCAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, FOR SUSPENSION / ORAL406 mgExact identifier — unii+route
80 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JPASTILLE / ORALNAExact identifier — unii+route
80 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route
80 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AMETHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JCAPSULE, DELAYED RELEASE / ORAL1321 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, DELAYED RELEASE / ORAL2834 mgExact identifier — unii+route
80 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, DELAYED RELEASE / ORAL46 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, FOR SUSPENSION / ORAL406 mgExact identifier — unii+route
80 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JPASTILLE / ORALNAExact identifier — unii+route
80 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMCAPSULE, DELAYED RELEASE / ORAL70 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route
80 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JPASTILLE / ORALNAExact identifier — unii+route
80 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, DELAYED RELEASE / ORAL2834 mgExact identifier — unii+route
80 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMCAPSULE, DELAYED RELEASE / ORAL70 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GCAPSULE, DELAYED RELEASE / ORAL78 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AMETHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JCAPSULE, DELAYED RELEASE / ORAL1321 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
HYPROMELLOSE 2208 (3 MPA.S)HYPROMELLOSE 2208 (3 MPA.S)9H4L916OBUCAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, CHEWABLE / ORAL50 mgExact identifier — unii+route
80 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route
80 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route
80 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, DELAYED RELEASE / ORAL366 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, DELAYED RELEASE / ORAL46 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GCAPSULE, DELAYED RELEASE / ORAL78 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, DELAYED RELEASE / ORAL366 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)5KY68S2577CAPSULE, DELAYED RELEASE / ORAL107 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JCAPSULE / ORAL401 mgExact identifier — unii+route
80 equally ranked IID candidates
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)5KY68S2577CAPSULE, DELAYED RELEASE / ORAL107 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JCAPSULE, EXTENDED RELEASE / ORAL301.7 mgExact identifier — unii+route
80 equally ranked IID candidates
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)5KY68S2577CAPSULE, DELAYED RELEASE / ORAL107 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, COATED / ORAL333.3 mgExact identifier — unii+route
80 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route
80 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, COATED / ORAL333.3 mgExact identifier — unii+route
80 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GCAPSULE, DELAYED RELEASE / ORAL78 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii+route+dosage form
8 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
A078878-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05

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 22:38:342026-08A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0584e616aacf4f…
2026-08-18 06:07:402026-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053f01610625f2…
2019-09-15 20:21 UTC2019-09A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05f41ea6bd6efb…

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
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Limited0e8fde83-a55c-edaf-3c66-e1fc77d0bc112025-05-28WarningsExact identifier
ndc (package): 55111-397-27
ndc (package): 55111-397-33
ndc (package): 55111-397-39
ndc (package): 55111-397-52
ndc (package): 55111-397-74
ndc (package): 55111-397-28
ndc (package): 55111-397-42
ndc (product): 55111-397
ndc11 (package): 55111039728
ndc11 (package): 55111039739
ndc11 (package): 55111039733
ndc11 (package): 55111039752
ndc11 (package): 55111039727
ndc11 (package): 55111039742
ndc11 (package): 55111039774
spl id: fff9af9d-87b4-7d54-4cc4-c65b07556ec5
spl set id: 0e8fde83-a55c-edaf-3c66-e1fc77d0bc11

Reported adverse events (FAERS/openFDA)#

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