calcium gluconate

Product NDC: 70518-4355
11-digit product format: 705184355
Labeler code: 70518
Product ID: 70518-4355_37609565-10ea-35bc-e063-6394a90afc3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: calcium gluconate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: REMEDYREPACK INC.
Application: ANDA213071
Marketing category: ANDA
Marketing start: 2025-06-11
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213071-001	CALCIUM GLUCONATE	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14
A213071-002	CALCIUM GLUCONATE	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19
A213071-003	CALCIUM GLUCONATE	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213071-001	AP
A213071-002	AP
A213071-003	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 · 62 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	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213071-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213071-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213071-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213071-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213071-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213071-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213071-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213071-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213071-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213071-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213071-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213071-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213071-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213071-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213071-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213071-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213071-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213071-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213071-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213071-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213071-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213071-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213071-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213071-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213071-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213071-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213071-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-14	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 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	A213071-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213071-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213071-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213071-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213071-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213071-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213071-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213071-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213071-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213071-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213071-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213071-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213071-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213071-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213071-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213071-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213071-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213071-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213071-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213071-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213071-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213071-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213071-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213071-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213071-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213071-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213071-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213071-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213071-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213071-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213071-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213071-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213071-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213071-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213071-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213071-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213071-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213071-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213071-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213071-001	AP	1	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A213071-001	CGT	2023-05-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213071-001	CGT	2023-05-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213071-001	CGT	2023-05-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213071-001	CGT	2023-05-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213071-001	CGT	2023-05-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213071-001	CGT	2023-05-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213071-001	CGT	2023-05-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213071-001	CGT	2023-05-05	`3a93d1ddd44b…`

Additional Listing Data#

Finished product: Yes
Brand name base: calcium gluconate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CALCIUM GLUCONATE MONOHYDRATE	98 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
d6db3a1c-ed02-48fc-9134-ea1d58acf42e	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	Strength	SPL version
70518-4355-0	calcium gluconate	25 in 1 CARTON	INJECTION, SOLUTION	25		2
70518-4355-1	calcium gluconate	10 mL in 1 VIAL	INJECTION, SOLUTION	10		2

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcium Gluconate	CALCIUM GLUCONATE	Henry Schein, Inc.	3cbf6bf7-2415-4435-b3df-41855514a05d	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213071 application number: ANDA213071
calcium gluconate	CALCIUM GLUCONATE	REMEDYREPACK INC.	d6db3a1c-ed02-48fc-9134-ea1d58acf42e	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213071 application number: ANDA213071 ndc (product): 70518-4355
calcium gluconate	CALCIUM GLUCONATE	Hikma Pharmaceuticals USA Inc.	8ec4d137-1e9b-40e2-aeb2-8f62626a8fa5	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213071 application number: ANDA213071
calcium gluconate	CALCIUM GLUCONATE	Hikma Pharmaceuticals USA Inc.	ce7becd8-cf59-4470-aac8-82761a24ebd7	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213071 application number: ANDA213071
calcium gluconate	CALCIUM GLUCONATE	Hikma Pharmaceuticals USA Inc.	313a4ea9-178b-495e-9bc7-af1860fa6501	2023-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213071 application number: ANDA213071

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	d6db3a1c-ed02-48fc-9134-ea1d58acf42e	2
1668250	10 ML calcium gluconate 100 MG/ML Injection	SCD	d6db3a1c-ed02-48fc-9134-ea1d58acf42e	2
1668250	calcium gluconate 10 % per 10 ML Injection	SY	d6db3a1c-ed02-48fc-9134-ea1d58acf42e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4355-0	70518435500	25 VIAL in 1 CARTON (70518-4355-0) / 10 mL in 1 VIAL (70518-4355-1)	25 vial	2025-06-11	No	No	Current
70518-4355-1	70518435501	10 mL in 1 VIAL	10 ml				Historical