Indications and uses
• 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
• 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
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days may take 1 to 4 days for full effect 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 • swallow whole. Do not crush or chew capsules • do not use for more than 14 days unless directed by y...
• read the directions and warnings before use • keep the carton. It contains important information. • store at 20-25°C (68-77°F)
Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)
Acid reducer
• 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
Allergy alert:
• Do not use if you are allergic to esomeprazole
• Esomeprazole may cause severe skin reactions. Symptoms include:
o skin reddening
o blisters
o rash
If an allergic reaction occurs, stop use and seek medical attention right away.
• 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.
• 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
• taking a prescription drug. Acid reducers may interact with certain prescription drugs.
• 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
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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
• swallow whole. Do not crush or chew capsules
• do not use for more than 14 days unless directed by your doctor
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
• read the directions and warnings before use
• keep the carton. It contains important information.
• store at 20-25°C (68-77°F)
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg
Inactive ingredients black iron oxide, eudragit, FD&C Blue 1, FD&C Red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate.
Esomeprazole Magnesium Delayed-Release Capsules 20 mg (Mini Capsules)
Inactive ingredients black iron oxide, corn starch, D&C red 27 aluminum lake, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate
Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
Tips for Managing Heartburn
• Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
• Eat slowly and do not eat big meals.
• Do not eat late at night or just before bedtime.
• Do not lie flat or bend over soon after eating.
• Raise the head of your bed.
• Wear loose-fitting clothing around your stomach.
• If you are overweight, lose weight.
• If you smoke, quit smoking.
Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA
Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India
NDC: 25000-075-76
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg
14 count bottle label

NDC: 25000-075-76
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg
14 count carton label
NDC: 25000-112-76
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules)
14 count bottle label
NDC: 25000-112-76
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules)
14 count carton label
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | 6 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | 6 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | 6 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule | SY | 6 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ESOMEPRAZOLE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7006a36-e68d-42e2-8cd3-d725cb2e47b1 | Product name | 6 | 20251027 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 9 | 20180628 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 8 | 20171212 |
| 094c6751-235c-4d12-acee-2baf94f676f4 | Product name | 1 | 20151116 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 25000-075-76 | Esomeprazole Magnesium Delayed-Release Capsules, 20 mg | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | 6 | |
| 25000-075-76 | Esomeprazole Magnesium Delayed-Release Capsules, 20 mg | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | 6 | |
| 25000-112-76 | Esomeprazole Magnesium Delayed-Release 20 mg mini | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | 6 | |
| 25000-112-76 | Esomeprazole Magnesium Delayed-Release 20 mg mini | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | 6 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 25000-075 | ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG CAPSULE, DELAYED RELEASE ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG MINI CAPSULE, DELAYED RELEASE [MARKSANS PHARMA LIMITED] | 6 | Current NDC, 2 package rows | 20240319_32f26c74-3052-4a69-9dc7-d18f9d761a8b.zip |
| 25000-112 | ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG CAPSULE, DELAYED RELEASE ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG MINI CAPSULE, DELAYED RELEASE [MARKSANS PHARMA LIMITED] | 6 | Current NDC, 2 package rows | 20240319_32f26c74-3052-4a69-9dc7-d18f9d761a8b.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 25000-075 | 25000-075-76 |
| 25000-112 | 25000-112-76 |
Every source-derived ingredient row is available through these pages.
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217264-001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 9b2671bbb829… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Esomeprazole Magnesium Delayed-Release Capsules, 20 mg | ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG | MARKSANS PHARMA LIMITED | 32f26c74-3052-4a69-9dc7-d18f9d761a8b | 2024-03-18 | Warnings | 25000-112-76 25000-075-76 25000-112 25000-075 25000007576 25000011276 2c8804c8-f28d-4381-ad8b-708009989b57 32f26c74-3052-4a69-9dc7-d18f9d761a8b |
Adverse event summaries are temporarily unavailable. Other product information remains available.