Calcium Gluconate

Product NDC: 63323-360
11-digit product format: 633230360
Labeler code: 63323
Product ID: 63323-360_3e4a7e0e-c7f4-4aa0-8c9c-0aa3fd7dc729
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcium Gluconate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: NDA208418
Marketing category: NDA
Marketing start: 2017-06-15
Substance: CALCIUM GLUCONATE MONOHYDRATE
Active strength: 98 mg/mL
Pharmacologic classes: Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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CHLORIDE	CALCIUM GLUCONATE	1GM/50ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2021-06-17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CHLORIDE	CALCIUM GLUCONATE	2GM/100ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2021-06-17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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Calcium Gluconate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CALCIUM GLUCONATE MONOHYDRATE	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CZN0MI5R31	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197435	Internal RxNorm lookup
1668248	Internal RxNorm lookup
1668250	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8b77c3d2-992d-4261-8421-9cfd07328fbf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-360-01	Calcium Gluconate	10 mL in 1 VIAL, PLASTIC	INJECTION, SOLUTION	10	6
63323-360-03	Calcium Gluconate	50 mL in 1 VIAL, PLASTIC	INJECTION, SOLUTION	50	6
63323-360-05	Calcium Gluconate	100 mL in 1 VIAL, PLASTIC	INJECTION, SOLUTION	100	6
63323-360-19	Calcium Gluconate	25 in 1 TRAY	INJECTION, SOLUTION	25	6
63323-360-59	Calcium Gluconate	25 in 1 TRAY	INJECTION, SOLUTION	25	6
63323-360-61	Calcium Gluconate	20 in 1 TRAY	INJECTION, SOLUTION	20	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-360-01	ML - Milliliter	63323-360	1d434d18-2915-46fe-a4fd-26c3adca0176	1	2017-10-13
63323-360-03	ML - Milliliter	63323-360	5cc8d670-ba3a-4eec-b5dc-bec4a770a71c	1	2017-10-13
63323-360-05	ML - Milliliter	63323-360	353fb39c-9d1e-4a17-b179-6ab947827319	1	2017-10-13
63323-360-19	ML - Milliliter	63323-360	faa54ab9-88fe-45ad-998c-b85cd78b6986	1	2017-10-13
63323-360-59	ML - Milliliter	63323-360	fa4b02da-a263-415b-aa3c-c0eb1618003d	1	2017-10-13
63323-360-61	ML - Milliliter	63323-360	322c87e1-c87a-4ced-b4cf-499d1c46841b	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-360	CALCIUM GLUCONATE (CALCIUM GLUCONATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	6	Current NDC, Legacy NDC, 6 package rows	20230808_8b77c3d2-992d-4261-8421-9cfd07328fbf.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 · 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
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
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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CZN0MI5R31	CALCIUM GLUCONATE MONOHYDRATE	66905-23-5	CALCIUM GLUCONATE MONOHYDRATE
SQE6VB453K	CALCIUM GLUCONATE	299-28-5	Calcium Gluconate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1668250	calcium gluconate 1 GM in 10 ML (10 % ) Injection	PSN	788ab6d7-d80c-0220-e053-2991aa0ae6e9	5
1668250	10 ML calcium gluconate 100 MG/ML Injection	SCD	788ab6d7-d80c-0220-e053-2991aa0ae6e9	5
1668250	calcium gluconate 10 % per 10 ML Injection	SY	788ab6d7-d80c-0220-e053-2991aa0ae6e9	5
1668248	calcium gluconate 5 GM in 50 ML (10 % ) Injection	PSN	7d93251a-b555-0be0-e053-2991aa0ad764	4
1668248	50 ML calcium gluconate 100 MG/ML Injection	SCD	7d93251a-b555-0be0-e053-2991aa0ad764	4
1668248	calcium gluconate 10 % per 50 ML Injection	SY	7d93251a-b555-0be0-e053-2991aa0ad764	4
1668250	calcium gluconate 1 GM in 10 ML (10 % ) Injection	PSN	4c635f60-7868-46d5-b932-d5cf8fc84432	3
1668250	10 ML calcium gluconate 100 MG/ML Injection	SCD	4c635f60-7868-46d5-b932-d5cf8fc84432	3
1668250	calcium gluconate 10 % per 10 ML Injection	SY	4c635f60-7868-46d5-b932-d5cf8fc84432	3
1668250	calcium gluconate 1 GM in 10 ML (10 % ) Injection	PSN	38413366-b558-7dd0-e063-6394a90acb7e	2
1668250	calcium gluconate 1 GM in 10 ML (10 % ) Injection	PSN	b6226367-b061-eec5-e053-2a95a90a617d	2
1668250	10 ML calcium gluconate 100 MG/ML Injection	SCD	38413366-b558-7dd0-e063-6394a90acb7e	2
1668250	10 ML calcium gluconate 100 MG/ML Injection	SCD	b6226367-b061-eec5-e053-2a95a90a617d	2
1668250	calcium gluconate 10 % per 10 ML Injection	SY	38413366-b558-7dd0-e063-6394a90acb7e	2
1668250	calcium gluconate 10 % per 10 ML Injection	SY	b6226367-b061-eec5-e053-2a95a90a617d	2
1668250	calcium gluconate 1 GM in 10 ML (10 % ) Injection	PSN	d98cdf54-0dce-459f-881f-3b6c6e6185fe	1
1668250	10 ML calcium gluconate 100 MG/ML Injection	SCD	d98cdf54-0dce-459f-881f-3b6c6e6185fe	1
1668250	calcium gluconate 10 % per 10 ML Injection	SY	d98cdf54-0dce-459f-881f-3b6c6e6185fe	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-360-01	63323036001	10 mL in 1 VIAL, PLASTIC	10 ml					Historical
63323-360-03	63323036003	50 mL in 1 VIAL, PLASTIC	50 ml					Historical
63323-360-05	63323036005	100 mL in 1 VIAL, PLASTIC	100 ml					Historical
63323-360-19	63323036019	25 VIAL, PLASTIC in 1 TRAY (63323-360-19) / 10 mL in 1 VIAL, PLASTIC (63323-360-01)		2017-06-15	0000-00-00	No	No	Current
63323-360-59	63323036059	25 VIAL, PLASTIC in 1 TRAY (63323-360-59) / 50 mL in 1 VIAL, PLASTIC (63323-360-03)		2017-06-15	0000-00-00	No	No	Current
63323-360-61	63323036061	20 VIAL, PLASTIC in 1 TRAY (63323-360-61) / 100 mL in 1 VIAL, PLASTIC (63323-360-05)		2017-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Calcium Gluconate	Fresenius Kabi USA, LLC	2026-05-18	HUMAN PRESCRIPTION DRUG LABEL	7
Calcium Gluconate	Henry Schein, Inc.	2025-11-03	HUMAN PRESCRIPTION DRUG LABEL	7
Calcium Gluconate	REMEDYREPACK INC.	2025-09-29	HUMAN PRESCRIPTION DRUG LABEL	3
Calcium Gluconate	ProPharma Distribution	2025-07-18	HUMAN PRESCRIPTION DRUG LABEL	2
CALCIUM GLUCONATE INJECTION, USP 10% 1,000 mg per 10mL (100mg/mL) 10mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2024-02-01	HUMAN PRESCRIPTION DRUG LABEL	5
Calcium Gluconate	Medical Purchasing Solutions, LLC	2023-05-04	HUMAN PRESCRIPTION DRUG LABEL	2
Calcium Gluconate	General Injectables and Vaccines, Inc.	2022-12-13	HUMAN PRESCRIPTION DRUG LABEL	4
CALCIUM GLUCONATE INJECTION, USP 5,000mg PER 50mL (100mg/mL) 50mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2022-12-10	HUMAN PRESCRIPTION DRUG LABEL	4
Calcium Gluconate	A-S Medication Solutions	2018-10-09	Human Prescription Drug Label	1