Esomeprazole sodium

Product NDC: 14335-060
11-digit product format: 143350060
Labeler code: 14335
Product ID: 14335-060_d8054c01-c776-3c25-e053-2a95a90a0998
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esomeprazole sodium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Hainan Poly Pharm. Co., Ltd.
Application: ANDA215732
Marketing category: ANDA
Marketing start: 2021-01-31
Marketing end: 0000-00-00
Substance: ESOMEPRAZOLE SODIUM
Active strength: 40 mg/5mL
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	14335-060		I	Inactivated by FDA		2026-08-11
excluded package	package	14335-060	14335-060-01	I	Inactivated by FDA		2026-08-11

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

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
A215732-001	ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RS	2022-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215732-001	AP

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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RS	2022-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RS	2022-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RS	2022-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RS	2022-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RS	2022-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RS	2022-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RS	2022-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RS	2022-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RS	2022-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RS	2022-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-02-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215732-001	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RS	2022-02-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215732-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215732-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215732-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215732-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215732-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215732-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215732-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215732-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215732-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215732-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215732-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215732-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215732-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215732-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215732-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215732-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215732-001	AP	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215732-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215732-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215732-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215732-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215732-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215732-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215732-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215732-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215732-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215732-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215732-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215732-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215732-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215732-001	AP	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1	Product name	6	20251027
d71865e8-5c35-4d76-8ecd-a7adda982240	Product name	9	20180628
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
14335-060-01	2026-01-29	C162847	48780-1	49896155-ac18-586f-e063-e6dba90add90	These highlights do not include all the information needed to use ESOMEPRAZOLE SODIUM FOR INJECTION safely and effectively. See full prescribing information for ESOMEPRAZOLE SODIUM FOR INJECTION ESOMEPRAZOLE SODIUM for Injection, for intravenous use Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
14335-060-01	Esomeprazole sodium	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		1
14335-060-01	Esomeprazole sodium	5 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14335-060	ESOMEPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HAINAN POLY PHARM. CO., LTD.]	1	Legacy NDC, 2 package rows	20220215_d6635546-be95-4df0-b311-c6d74a4258e7.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole sodium	ESOMEPRAZOLE SODIUM	Slate Run Pharmaceuticals, LLC	23395673-116d-4a8e-b0ce-59f9ca5b3daf	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215732 application number: ANDA215732

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L2C9GWQ43H	ESOMEPRAZOLE SODIUM	161796-78-7	ESOMEPRAZOLE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
486501	esomeprazole 40 MG Injection	PSN	d6635546-be95-4df0-b311-c6d74a4258e7	1
486501	esomeprazole 40 MG Injection	SCD	d6635546-be95-4df0-b311-c6d74a4258e7	1
486501	esomeprazole 40 MG (as esomeprazole sodium 42.5 MG) Injection	SY	d6635546-be95-4df0-b311-c6d74a4258e7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
14335-060-01	14335006001	10 VIAL in 1 CARTON (14335-060-01) > 5 mL in 1 VIAL	10 vial	2021-01-31	0000-00-00	No	No	Current