Omeprazole Magnesium DR Capsules 20.6 mg

Manufacturer: Dr. Reddy's Laboratories Limited
Effective date: 2020-02-04
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 23:40:34

Label at a glance#

ProductOmeprazole Magnesium

Active ingredientOmeprazole Magnesium

Label structure2 sections

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DR. REDDY'S

NDC 55111-397-89
Count :
1,500 Capsules

Omeprazole Magnesium Delayed-Release Capsules 20.6 mg
(equivalent to 20 mg omeprazole)

Batch No. :

Mfg. Date :

Repack Before :

Expiration Date :

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]

Caution: For manufacturing, processing or repackaging only.

DO NOT OPEN POUCHES UNTIL REPACKAGING

Mfd. by : Dr. Reddy's Laboratories Limited
Bachupally - 500 090 INDIA

150071750

M.L. 59/RR/AP/97/F/R

Omeprazole_Foil Pouch

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55111-397-89	2020-02-19	C162847	48780-1	9d75b9d0-2ea2-f424-e053-dadaa90a57ce	Omeprazole Magnesium DR Capsules 20.6 mg
55111-397-89	2020-01-31	C162847	48780-1	9d75b9d0-2ea2-f424-e053-dadaa90a57ce	Omeprazole Magnesium DR Capsules 20.6 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-397-27	EA - Each	55111-397	cb783e2e-a92f-4544-908b-095fd6075f3f	1	2015-09-10
55111-397-28	EA - Each	55111-397	3a546396-9702-499f-8c97-c73cf8ec977a	1	2012-07-24
55111-397-33	EA - Each	55111-397	58ac9e87-c988-410b-b086-0aa500956a49	1	2015-09-10
55111-397-42	EA - Each	55111-397	fbe87769-c688-436e-bf0c-6659b849179b	1	2012-07-24
55111-397-52	EA - Each	55111-397	03066f2b-a765-4b49-a5d7-503ff8fffe07	1	2013-03-03
55111-397-74	EA - Each	55111-397	518a761d-8d23-42b2-9c1d-fa2a0f566211	1	2012-07-24

Products#

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

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

Omeprazole Magnesium
Omeprazole
Ferrosoferric Oxide
Anhydrous Dibasic Calcium Phosphate
Gelatin
Glyceryl Monostearate
Hypromellose 2910 (3 Mpa.S)
Magnesium Oxide
Magnesium Stearate
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A
Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)
Cellulose, Microcrystalline
Polysorbate 80
Propylene Glycol
Shellac
Silicon Dioxide
Sodium Lauryl Sulfate
Talc
Titanium Dioxide
Ferric Oxide Red
Raw Sugar
Potassium Hydroxide
Triethyl Citrate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55111-397	55111-397-89

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
Omeprazole Magnesium	426QFE7XLK	ACTIM
Ferrosoferric Oxide	XM0M87F357	IACT
Anhydrous Dibasic Calcium Phosphate	L11K75P92J	IACT
Gelatin	2G86QN327L	IACT
Glyceryl Monostearate	230OU9XXE4	IACT
Hypromellose 2910 (3 Mpa.S)	0VUT3PMY82	IACT
Magnesium Oxide	3A3U0GI71G	IACT
Magnesium Stearate	70097M6I30	IACT
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A	NX76LV5T8J	IACT
Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)	5KY68S2577	IACT
Cellulose, Microcrystalline	OP1R32D61U	IACT
Polysorbate 80	6OZP39ZG8H	IACT
Propylene Glycol	6DC9Q167V3	IACT
Shellac	46N107B71O	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Sodium Lauryl Sulfate	368GB5141J	IACT
Talc	7SEV7J4R1U	IACT
Titanium Dioxide	15FIX9V2JP	IACT
Ferric Oxide Red	1K09F3G675	IACT
Raw Sugar	8M707QY5GH	IACT
Potassium Hydroxide	WZH3C48M4T	IACT
Triethyl Citrate	8Z96QXD6UM	IACT

Source Document#

Source XML

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078878-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RS	2009-06-05

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`f41ea6bd6efb…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Limited	0e8fde83-a55c-edaf-3c66-e1fc77d0bc11	2025-05-28	Warnings	Exact identifier ndc (product): 55111-397
879ff4a5-833c-f57b-3970-aeed17688cac			fe870574-6a7c-5fbb-999e-80ad5af1799b	2020-02-04		Exact identifier spl id: 879ff4a5-833c-f57b-3970-aeed17688cac spl set id: fe870574-6a7c-5fbb-999e-80ad5af1799b

Reported adverse events (FAERS/openFDA)#

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