Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg
- Manufacturer
- Rising Pharma Holdings, Inc. | Graviti Pharmaceuticals Private Limited
- Effective date
- 2026-04-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- monthly-update
- Hydrated at
- 2026-07-17 21:36:00
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
DESCRIPTION SECTION
| Active ingredient (in each capsule) | Purpose |
| Esomeprazole 20 mg | Acid reducer |
| (Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate) | |
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
Warnings:
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 allergic reaction occurs, stop use and seek medical help right away.
Do not use if you have:
- 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
- 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
• taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Stop use and ask a doctor if
- 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.
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.
Directions
- 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 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
- children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
Other Information
- read the directions and warnings before use
- keep the carton. It contains important information.
- Store at 20° to 25°C (68° to 77°F).
Inactive Ingredients
FD&C Blue No.2, gelatin, hypromellose, hydroxy propyl cellulose, magnesium stearate, methacrylic acid & ethyl acrylate copolymer dispersion, mono and di glycerides, pharmaceutical ink, polysorbate 80, sugar spheres, talc, triethyl citrate.
Questions or comments?
Call 1-844-474-7464
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 by:
Graviti Pharnaceuticals Pvt. Ltd.
Telangana-502307, INDIA.
M.L.No.: 12/SRD/TS/2017/F/G
Revised: 04/2026
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel - 20 mg Capsules: Container Label
NDC 64980-664-41
Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg
24 HR
Acid Reducer
Treats Frequent Heartburn
May take 1 to 4 days for full effect
14 Capsules
One 14-day course of treatment
Distributed by: Rising Pharma Holdings, Inc.

Principal Display Panel - 20 mg Capsules: Carton Label
NDC 64980-664-41
Compare to the active ingredient in Nexium®24HR"
Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg
24 HR
Acid Reducer
Treats Frequent Heartburn
May take 1 to 4 days for full effect
14 Capsules
One 14-day course of treatment
Distributed by: Rising Pharma Holdings, Inc.


Principal Display Panel - 20 mg Capsules: Carton Label
NDC 64980-664-19
Compare to the active ingredient in Nexium® 24HR"
Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg
24 HR
Acid Reducer
Treats Frequent Heartburn
May take 1 to 4 days for full effect
42 Capsules
Three 14-day courses of treatment
Distributed by: Rising Pharma Holdings, Inc.


Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0364980664196 | GTIN-13: 0364980664196 EAN-13: 0364980664196 GTIN-12: 364980664196 UPC-A: 364980664196 GTIN storage (14 digits): 00364980664196 | b0715b2b-3453-4088-891d-91a1aa22f57d-04.jpg |
| Barcode | EAN-13 | 0364980664417 | GTIN-13: 0364980664417 EAN-13: 0364980664417 GTIN-12: 364980664417 UPC-A: 364980664417 GTIN storage (14 digits): 00364980664417 | b0715b2b-3453-4088-891d-91a1aa22f57d-02.jpg |
Products#
Every source-derived product name is available through these pages.
- ESOMEPRAZOLE MAGNESIUM
- ESOMEPRAZOLE
- RAW SUGAR
- POLYSORBATE 80
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- TALC
- MAGNESIUM STEARATE
- METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
- TRIETHYL CITRATE
- GELATIN, UNSPECIFIED
- FD&C BLUE NO. 2
- GLYCERYL MONOSTEARATE
- GLYCERYL DISTEARATE
- HYPROMELLOSE, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 64980-664 | 64980-664-41, 64980-664-19 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216349-001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 |
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.
| 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 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216349-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2022-06-24 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | Rising Pharma Holdings, Inc. | 2164e1d7-e601-4ce5-be29-0c21c3a5a647 | 2026-04-16 | 64980-664-19 64980-664-41 64980-664 64980066419 64980066441 b0715b2b-3453-4088-891d-91a1aa22f57d 2164e1d7-e601-4ce5-be29-0c21c3a5a647 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.