Application 021117

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	CALCIUM CHLORIDE	INJECTABLE;INJECTION	100MG/ML	Yes	Yes

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
N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	CALCIUM CHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021117-001	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 · 41 observed 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	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N021117-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021117-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021117-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021117-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021117-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021117-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021117-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021117-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021117-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021117-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021117-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021117-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021117-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021117-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021117-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021117-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021117-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021117-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021117-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021117-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021117-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021117-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021117-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021117-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021117-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021117-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021117-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021117-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021117-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021117-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021117-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021117-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021117-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021117-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021117-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021117-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021117-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021117-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021117-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021117-001	AP	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcium Chloride	CALCIUM CHLORIDE	Hospira, Inc.	c4c65e48-85f8-4dcf-6281-06e40959cc79	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021117 application number: NDA021117 ndc (product): 0409-1631
Calcium Chloride	CALCIUM CHLORIDE	Henry Schein, Inc.	0a3b8e0e-efb0-465b-84cb-d120b3096ebd	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021117 application number: NDA021117 ndc (product): 0404-9830
CALCIUM CHLORIDE	CALCIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a9500f41-8041-d753-e053-2a95a90a6f3c	2024-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021117 application number: NDA021117 ndc (product): 51662-1452
Calcium Chloride	CALCIUM CHLORIDE	Medical Purchasing Solutions, LLC	6685165a-0df7-0ae0-e053-2a91aa0a3f22	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021117 application number: NDA021117 ndc (product): 71872-7045

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9830	Calcium Chloride	Calcium Chloride	Henry Schein, Inc.	NDA	Current
0404-9830	Calcium Chloride	Calcium Chloride	Henry Schein, Inc.	NDA	Current
0409-1631	Calcium Chloride	CALCIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-1631	Calcium Chloride	CALCIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-1631	Calcium Chloride	CALCIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-1631	Calcium Chloride	CALCIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-1631	Calcium Chloride	CALCIUM CHLORIDE	Hospira, Inc.	NDA	Current
51662-1452	CALCIUM CHLORIDE	CALCIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-631	Calcium Chloride	Calcium Chloride	General Injectables & Vaccines, Inc	NDA	Current
52584-631	Calcium Chloride	Calcium Chloride	General Injectables & Vaccines, Inc	NDA	Current
52584-631	Calcium Chloride	Calcium Chloride	General Injectables & Vaccines, Inc	NDA	Current
52584-631	Calcium Chloride	Calcium Chloride	General Injectables & Vaccines, Inc	NDA	Current
52584-631	Calcium Chloride	Calcium Chloride	General Injectables & Vaccines, Inc	NDA	Current
52584-631	Calcium Chloride	Calcium Chloride	General Injectables & Vaccines, Inc	NDA	Current
55154-3196	Calcium Chloride	CALCIUM CHLORIDE	Cardinal Health	NDA	Current
55154-3196	Calcium Chloride	CALCIUM CHLORIDE	Cardinal Health	NDA	Current
71872-7045	Calcium Chloride	CALCIUM CHLORIDE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7045	Calcium Chloride	CALCIUM CHLORIDE	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74233	SUPPL	2023-05-12
74230	SUPPL	2023-05-12
71434	SUPPL	2022-06-24
56507	SUPPL	2019-03-18
55008	SUPPL	2018-07-26
41959	ORIG	2004-03-08
26811	SUPPL	2003-03-26
26810	ORIG	2000-01-28