Esomeprazole Magnesium

Product NDC: 68382-848
11-digit product format: 683820848
Labeler code: 68382
Product ID: 68382-848_bc31956a-671b-4ca3-b9dd-1fdb03003cae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esomeprazole Magnesium
Dosage form: GRANULE, DELAYED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA206055
Marketing category: ANDA
Marketing start: 2023-06-30
Substance: ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active strength: 20 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206055-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB		2023-06-07
A206055-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB		2023-06-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A206055-001	AB
A206055-002	AB

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206055-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206055-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2023-06-07	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206055-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206055-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206055-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206055-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206055-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206055-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206055-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206055-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206055-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206055-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206055-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206055-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206055-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206055-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206055-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206055-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206055-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206055-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206055-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206055-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206055-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206055-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206055-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206055-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206055-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206055-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206055-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206055-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206055-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206055-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206055-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A206055-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206055-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A206055-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206055-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206055-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206055-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206055-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206055-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206055-002	AB	1	`a67488948f0b…`

Additional Listing Data#

Finished product: Yes
Brand name base: Esomeprazole Magnesium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
36H71644EQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
692576	Internal RxNorm lookup
692578	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
190a4c5b-1547-45d7-b00b-10da4131e2e2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1	Product name	6	20251027
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68382-848-94	Esomeprazole Magnesium	30 in 1 CARTON	GRANULE, DELAYED RELEASE	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-848	ESOMEPRAZOLE MAGNESIUM GRANULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	2	Current NDC, 1 package rows	20230819_190a4c5b-1547-45d7-b00b-10da4131e2e2.zip

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
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Zydus Lifesciences Limited	4cd9e802-c519-4593-bc38-947ad7f9b567	2024-11-28		Exact identifier application applno (ANDA): 206055 application number: ANDA206055
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Zydus Pharmaceuticals USA Inc.	190a4c5b-1547-45d7-b00b-10da4131e2e2	2023-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206055 application number: ANDA206055 ndc (product): 68382-848

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
36H71644EQ	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	217087-10-0	ESOMEPRAZOLE MAGNESIUM DIHYDRATE
R6DXU4WAY9	ESOMEPRAZOLE MAGNESIUM	217087-09-7	Esomeprazole Magnesium

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
692576	esomeprazole 20 MG Granules for Delayed Release Oral Suspension	PSN	190a4c5b-1547-45d7-b00b-10da4131e2e2	2
692578	esomeprazole 40 MG Granules for Delayed Release Oral Suspension	PSN	190a4c5b-1547-45d7-b00b-10da4131e2e2	2
692576	esomeprazole 20 MG Granules for Oral Suspension	SCD	190a4c5b-1547-45d7-b00b-10da4131e2e2	2
692578	esomeprazole 40 MG Granules for Oral Suspension	SCD	190a4c5b-1547-45d7-b00b-10da4131e2e2	2
692576	esomeprazole (as esomeprazole magnesium) 20 MG Granules for Delayed Release Oral Suspension	SY	190a4c5b-1547-45d7-b00b-10da4131e2e2	2
692576	esomeprazole 20 MG Granules for Delayed Release Oral Suspension	SY	190a4c5b-1547-45d7-b00b-10da4131e2e2	2
692578	esomeprazole 40 MG (equivalent to esomeprazole magnesium 44.5 MG) Granules for Delayed Release Oral Suspension	SY	190a4c5b-1547-45d7-b00b-10da4131e2e2	2
692578	esomeprazole 40 MG Granules for Delayed Release Oral Suspension	SY	190a4c5b-1547-45d7-b00b-10da4131e2e2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68382-848-94	68382084894	30 GRANULE, DELAYED RELEASE in 1 CARTON (68382-848-94)	2023-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esomeprazole Magnesium	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2023-08-17	HUMAN PRESCRIPTION DRUG LABEL	2