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
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
Omeprazole delayed-release capsules, USP 20 mg
(equivalent to 20.6 mg omeprazole magnesium USP)
Acid reducer
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.
These may be signs of a serious condition. See your doctor.
Acid reducers may interact with certain prescription drugs.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
black iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, gelatin, hypromellose, iron oxide red, macrogol, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, mono and di-glycerides, polysorbate 80, polyvinyl alcohol-part. hydrolyzed, potassium hydroxide, shellac, sodium lauryl sulphate, sugar spheres [liquid glucose, starch (maize), sucrose], talc, titanium dioxide, triethyl citrate.
Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/22/2009
AUROHEALTH
NDC 58602-837-05
See current Drug Facts
Omeprazole
Delayed-Release Capsules, USP
20 mg/Acid Reducer
Treats Frequent Heartburn!
24 HR
14 Capsules
One 14-Day Course of Treatment
May take 1 to 4 days for full effect
AUROHEALTH
NDC 58602-837-05
See current Drug Facts
*Compare to the active
ingredient in Prilosec OTC®
Omeprazole
Delayed-Release
Capsules, USP
20 mg/Acid Reducer
Treats
Frequent
Heartburn!
24 HR
OZM 20
14 Capsules
One 14-Day Course of Treatment
May Take 1 to 4 days for full effect
| Class | Version | Type | Effective |
|---|---|---|---|
| OMEPRAZOLE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 873ef493-6b37-49d8-ac7f-bfca4117d2c1 | Product name | 5 | 20210607 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| f33561b9-47cb-411c-a228-16c62e346cd4 | Product name | 1 | 20200415 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58602-837-05 | Omeprazole | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | 2 | |
| 58602-837-05 | Omeprazole | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58602-837 | 58602-837-05 |
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 |
|---|---|---|---|---|---|---|---|
| A213201-001 | OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 |
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 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 3f0d92c62455… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213201-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-04-28 | 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 |
|---|---|---|---|---|---|---|
| Omeprazole | OMEPRAZOLE | Aurohealth LLC | 19097902-a5e6-423a-8569-31c569cd3cdb | 2024-02-19 | Warnings | 58602-837-05 58602-837 58602083705 0c2600f3-e9de-4e73-8ee1-9aeb94d228e4 19097902-a5e6-423a-8569-31c569cd3cdb |
Adverse event summaries are temporarily unavailable. Other product information remains available.