Application 020002

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	33MG/100ML;30MG/100ML;860MG/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020002-001	RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP		1992-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020002-001	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 · 42 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
2026-08-18 06:07:40	2026-07	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020002-001	RINGER'S IN PLASTIC CONTAINER	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE / INJECTION	AP	1992-04-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020002-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020002-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020002-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020002-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020002-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020002-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020002-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020002-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020002-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020002-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020002-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020002-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020002-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020002-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020002-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020002-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020002-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020002-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020002-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020002-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020002-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020002-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020002-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020002-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020002-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020002-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020002-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020002-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020002-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020002-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020002-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020002-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020002-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020002-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020002-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020002-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020002-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020002-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020002-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020002-001	AP	1	`e64feba35796…`

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
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDE	B. Braun Medical Inc.	01721071-af03-4894-95c1-10b8bc64b888	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020002 application number: NDA020002 ndc (product): 0264-7780

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
0264-7780	Ringers	Sodium Chloride, Calcium Chloride, and Potassium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7780	Ringers	Sodium Chloride, Calcium Chloride, and Potassium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7780	Ringers	Sodium Chloride, Calcium Chloride, and Potassium Chloride	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84114	SUPPL	2025-11-06
84082	SUPPL	2025-11-06
69253	SUPPL	2021-11-05
69226	SUPPL	2021-11-04