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 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day swallow whole. Do not crush or chew tablets. do not use for more than 14 days unless directed by your doct...
Active ingredient (in each tablet)
*Esomeprazole 20 mg
(Each film-coated delayed-release tablet corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)
Acid reducer
Allergy alert:
■ Do not use if you are allergic to esomeprazole.
■ Esomeprazole 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.
These may be signs of a serious condition. See your doctor.
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. (1-800-222-1222)
14-Day Course of Treatment
Repeated 14-Day Courses (if needed)
Other information
colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, hypromellose, low substituted hydroxy propyl cellulose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, mono and di-glycerides, polyethylene glycol, polysorbate 80, red iron oxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide.
Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)
Tips for Managing Heartburn
DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Made in India
LEADER™
NDC 70000-0695-1
24 Hour
Esomeprazole
Magnesium
Delayed-Release Tablets, 20 mg*
Acid Reducer
COMPARE TO
NEXIUM® 24 HR
active ingredient**
100 % Money
Back Guarantee
Treats Frequent
Heartburn
May Take 1 to 4 Days
for Full Effect
14 TABLETS
One 14-Day Course
of Treatment Actual Size
SEE NEW WARNING INFORMATION

| 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 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 9 | 20180628 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 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 |
|---|---|---|---|---|---|---|
| 70000-0695-1 | Esomeprazole Magnesium | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | 1 | |
| 70000-0695-1 | Esomeprazole Magnesium | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | 1 | |
| 70000-0695-2 | Esomeprazole Magnesium | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | 1 | |
| 70000-0695-2 | Esomeprazole Magnesium | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70000-0695 | ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH] | 1 | Current NDC, 4 package rows | 20240702_90df7bbb-c55e-4a01-90b7-c118b65617a9.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70000-0695 | 70000-0695-1, 70000-0695-2 |
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 |
|---|---|---|---|---|---|---|---|
| A214473-001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | a67488948f0b… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214473-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2023-07-12 | 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 | ESOMEPRAZOLE MAGNESIUM | Cardinal Health | 90df7bbb-c55e-4a01-90b7-c118b65617a9 | 2024-06-27 | Warnings | 70000-0695-1 70000-0695-2 70000-0695 70000069501 70000069502 90df7bbb-c55e-4a01-90b7-c118b65617a9 90df7bbb-c55e-4a01-90b7-c118b65617a9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.