Application 208418

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCIUM GLUCONATE	CALCIUM GLUCONATE	SOLUTION;INTRAVENOUS	1GM/10ML (100MG/ML)	Yes	Yes
002	CALCIUM GLUCONATE	CALCIUM GLUCONATE	SOLUTION;INTRAVENOUS	5GM/50ML (100MG/ML)	Yes	Yes
003	CALCIUM GLUCONATE	CALCIUM GLUCONATE	SOLUTION;INTRAVENOUS	10GM/100ML (100MG/ML)	Yes	Yes
004	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	SOLUTION;INTRAVENOUS	1GM/50ML (20MG/ML)	Yes	No
005	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	SOLUTION;INTRAVENOUS	2GM/100ML (20MG/ML)	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208418-001	CALCIUM GLUCONATE	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15
N208418-002	CALCIUM GLUCONATE	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15
N208418-003	CALCIUM GLUCONATE	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15
N208418-004	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	1GM/50ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2021-06-17
N208418-005	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	2GM/100ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2021-06-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N208418-001	AP
N208418-002	AP
N208418-003	AP

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208418-004	10130646	2037-07-25		Drug product	2025-08-22
N208418-005	10130646	2037-07-25		Drug product	2025-08-22

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 5 · 194 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
2026-08-18 06:07:40	2026-07	N208418-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208418-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208418-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208418-004	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2021-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208418-005	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2021-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208418-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208418-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208418-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208418-004	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208418-005	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208418-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208418-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208418-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208418-004	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208418-005	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208418-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208418-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208418-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208418-004	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208418-005	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208418-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208418-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208418-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208418-004	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208418-005	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208418-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208418-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208418-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208418-004	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208418-005	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208418-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208418-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208418-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208418-004	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208418-005	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208418-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208418-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208418-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208418-004	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208418-005	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-17	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 101 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	N208418-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208418-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208418-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208418-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208418-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208418-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208418-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208418-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208418-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208418-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208418-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208418-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208418-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208418-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208418-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208418-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208418-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208418-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208418-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208418-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208418-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208418-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208418-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208418-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208418-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208418-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208418-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208418-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208418-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208418-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208418-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208418-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208418-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208418-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208418-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208418-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208418-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208418-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208418-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208418-001	AP	1	`d8e5a09893c0…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208418-004	10130646	2037-07-25	Drug product	2025-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208418-005	10130646	2037-07-25	Drug product	2025-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208418-004	10130646	2037-07-25	Drug product	2025-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208418-005	10130646	2037-07-25	Drug product	2025-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208418-004	10130646	2037-07-25	Drug product	2025-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208418-005	10130646	2037-07-25	Drug product	2025-08-22	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208418-004	10130646	2037-07-25	Drug product	2025-08-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208418-005	10130646	2037-07-25	Drug product	2025-08-22	`a50c72e98297…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcium Gluconate	CALCIUM GLUCONATE	Fresenius Kabi USA, LLC	8b77c3d2-992d-4261-8421-9cfd07328fbf	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208418 application number: NDA208418 ndc (product): 63323-360
Calcium Gluconate	CALCIUM GLUCONATE	Henry Schein, Inc.	841ea51f-dc0d-45ed-8b55-bb64640cb930	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208418 application number: NDA208418 ndc (product): 0404-9831
Calcium Gluconate	CALCIUM GLUCONATE	REMEDYREPACK INC.	4c635f60-7868-46d5-b932-d5cf8fc84432	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208418 application number: NDA208418
Calcium Gluconate	CALCIUM GLUCONATE	ProPharma Distribution	38413366-b558-7dd0-e063-6394a90acb7e	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208418 application number: NDA208418
Calcium Gluconate	CALCIUM GLUCONATE	Fresenius Kabi USA, LLC	1aaf5c76-e526-4d8b-887e-cc3c4f39cc8b	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208418 application number: NDA208418
Calcium Gluconate	CALCIUM GLUCONATE	Fresenius Kabi USA, LLC	7f5101e0-abf9-4fcf-8986-c799e3333434	2024-05-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208418 application number: NDA208418 ndc (product): 65219-164 ndc (product): 65219-162
CALCIUM GLUCONATE	CALCIUM GLUCONATE	HF Acquisition Co LLC, DBA HealthFirst	788ab6d7-d80c-0220-e053-2991aa0ae6e9	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208418 application number: NDA208418 ndc (product): 51662-1312
Calcium Gluconate	CALCIUM GLUCONATE	Medical Purchasing Solutions, LLC	b6226367-b061-eec5-e053-2a95a90a617d	2023-05-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208418 application number: NDA208418 ndc (product): 71872-7222
CALCIUM GLUCONATE	CALCIUM GLUCONATE	HF Acquisition Co LLC, DBA HealthFirst	7d93251a-b555-0be0-e053-2991aa0ad764	2022-12-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208418 application number: NDA208418 ndc (product): 51662-1347

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9831	Calcium Gluconate	Calcium Gluconate	Henry Schein, Inc.	NDA	Current
0404-9831	Calcium Gluconate	Calcium Gluconate	Henry Schein, Inc.	NDA	Current
50090-3398	Calcium Gluconate	Calcium Gluconate	A-S Medication Solutions	NDA	Current
51662-1312	CALCIUM GLUCONATE	CALCIUM GLUCONATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1312	CALCIUM GLUCONATE	CALCIUM GLUCONATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1312	CALCIUM GLUCONATE	CALCIUM GLUCONATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1312	CALCIUM GLUCONATE	CALCIUM GLUCONATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1347	CALCIUM GLUCONATE	CALCIUM GLUCONATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1347	CALCIUM GLUCONATE	CALCIUM GLUCONATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1347	CALCIUM GLUCONATE	CALCIUM GLUCONATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1347	CALCIUM GLUCONATE	CALCIUM GLUCONATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-360	Calcium Gluconate	Calcium Gluconate	General Injectables and Vaccines, Inc.	NDA	Current
52584-360	Calcium Gluconate	Calcium Gluconate	General Injectables and Vaccines, Inc.	NDA	Current
52584-360	Calcium Gluconate	Calcium Gluconate	General Injectables and Vaccines, Inc.	NDA	Current
63323-360	Calcium Gluconate	Calcium Gluconate	Fresenius Kabi USA, LLC	NDA	Current
63323-360	Calcium Gluconate	Calcium Gluconate	Fresenius Kabi USA, LLC	NDA	Current
63323-360	Calcium Gluconate	Calcium Gluconate	Fresenius Kabi USA, LLC	NDA	Current
65219-162	Calcium Gluconate	Calcium Gluconate	Fresenius Kabi USA, LLC	NDA	Current
65219-164	Calcium Gluconate	Calcium Gluconate	Fresenius Kabi USA, LLC	NDA	Current
71872-7222	Calcium Gluconate	Calcium Gluconate	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72406	SUPPL	2022-10-19
72404	SUPPL	2022-10-18
69808	SUPPL	2022-01-04
69801	SUPPL	2021-12-30
67875	SUPPL	2021-06-23
67863	SUPPL	2021-06-22
54464	SUPPL	2018-06-05
54230	ORIG	2018-05-17
48746	ORIG	2017-06-16
48730	ORIG	2017-06-16
52403	ORIG	1900-01-01
52402	ORIG	1900-01-01
52401	ORIG	1900-01-01