Application 076316

Type: ANDA
Sponsor: HAEMONETICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	900MG/100ML	No	No

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
A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	INJECTABLE / INJECTION	AP		2004-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076316-001	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.

Product history page 1 of 2 · 43 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
2026-09-14 22:38:34	2026-08	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076316-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2004-10-27	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076316-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076316-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076316-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076316-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076316-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076316-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076316-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076316-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076316-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076316-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076316-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076316-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076316-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076316-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076316-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076316-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076316-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076316-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076316-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076316-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076316-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076316-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076316-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076316-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076316-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076316-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076316-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076316-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076316-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076316-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076316-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076316-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076316-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076316-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076316-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076316-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076316-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076316-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076316-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076316-001	AP	1	`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 9 · 179 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nacl 0.9% Normal Saline Solution	SODIUM CHLORIDE	CHI FUNG TECHNOLOGY COMPANY	5a53c4c8-c9de-700c-e063-6394a90a3ab5	2026-08-31	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	YYBA CORP	597f3347-647c-3545-e063-6294a90abab2	2026-08-20	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e88	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Hypertonic Saline	SODIUM CHLORIDE	NAVEH PHARMA (1996) LTD	167c7a9c-1228-4fb2-a89c-d3e148386323	2026-07-30	Warnings	Name fallback generic name: SODIUM CHLORIDE
Hypertonic Saline Solution Sodium Chloride	SODIUM CHLORIDE	NAVEH PHARMA (1996) LTD	750ea4b1-de2b-4299-aaa2-331daf383d0d	2026-07-30	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Fresenius Medical Care de Mexico, S.A. de C.V.	9a1220fb-6853-45ae-838c-10d8596e1af7	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Fresenius Medical Care Renal Therapies Group, LLC	af5cdf1a-19f4-11e2-892e-0800200c9a66	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	LABORATORIOS GRIFOLS SA	eb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf	2026-07-15	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
WHWSWB 0.9% Saline	SODIUM CHLORIDE	Yiwu Huanshu E-commerce Co., Ltd	4e9c21e5-f2f9-90e4-e063-6394a90acfe2	2026-07-11	Warnings	Name fallback generic name: SODIUM CHLORIDE
WHWSWB 0.9% SALINE	SODIUM CHLORIDE	Yiwu Huanshu E-commerce Co., Ltd	5082b773-79b2-2501-e063-6394a90a170f	2026-07-11	Warnings	Name fallback generic name: SODIUM CHLORIDE
SALINE NASAL	SODIUM CHLORIDE	ALAINA HEALTHCARE PRIVATE LIMITED	ed30a7f9-7132-42da-9bed-63a9b1c80ab2	2026-07-07	Warnings	Name fallback generic name: SODIUM CHLORIDE
OHTrust Artifical Eyedrop	SODIUM CHLORIDE	Nanoplus Technology Co., Limited	2ea26d96-704b-17bb-e063-6394a90a7e27	2026-07-01	Warnings	Name fallback generic name: SODIUM CHLORIDE
0.9% Sodium Chloride Saline Solution	SODIUM CHLORIDE	Yunqi Cosmetics (Shenzhen) Co., Ltd	546af257-dbd1-11fc-e063-6394a90a8e0a	2026-06-16	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Cardinal Health 107, LLC	107af8bc-b6af-4b85-8c8a-ea757dcef1da	2026-06-12	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
SALINE CLEANING	SODIUM CHLORIDE	Guangzhou Huanmei Cosmetics Co., Ltd.	524f07cc-ddb9-dda5-e063-6394a90ac0a5	2026-05-21	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	a2a964f7-c3ec-4dfb-e3a0-6d8136a80397	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Sportpharm LLC	a2c111f6-74d5-4a5d-82ac-d0f237488cb8	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Method Pharmaceuticals, LLC	4b08859e-65bd-8255-e063-6394a90af614	2026-04-23	Warnings	Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE 1 GRAM	SODIUM CHLORIDE	Gendose Pharmaceuticals, LLC	ce988ae5-61c6-4324-90e1-a94c8a54d0d0	2026-04-13	Warnings	Name fallback generic name: SODIUM CHLORIDE
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye	SODIUM CHLORIDE	Walgreen Company	bda3b9db-5fc4-408c-a5ae-d1eeb3ee308d	2026-04-06	Warnings	Name fallback generic name: SODIUM CHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57826-441	HAEMONETICS 0.9 % Sodium Chloride	SODIUM CHLORIDE	Haemonetics Corporation	ANDA	Current
57826-441	HAEMONETICS 0.9 % Sodium Chloride	SODIUM CHLORIDE	Haemonetics Corporation	ANDA	Current
57826-441	HAEMONETICS 0.9 % Sodium Chloride	SODIUM CHLORIDE	Haemonetics Corporation	ANDA	Current