CALCIUM GLUCONATE

Product NDC: 80830-2363
11-digit product format: 808302363
Labeler code: 80830
Product ID: 80830-2363_2bd614b6-02ce-49e3-86e2-dfaec7a13e04
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: calcium gluconate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Amneal Pharmaceuticals Private Limited
Application: ANDA217174
Marketing category: ANDA
Marketing start: 2023-09-08
Substance: CALCIUM GLUCONATE MONOHYDRATE
Active strength: 20 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2023-09-05
A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2023-09-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A217174-001	AP
A217174-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2023-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2023-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2023-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2023-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS		RS	2023-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS		RS	2023-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217174-001	CALCIUM GLUCONATE IN SODIUM CHLORIDE	1GM/50ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217174-002	CALCIUM GLUCONATE IN SODIUM CHLORIDE	2GM/100ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP		2023-09-05	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A217174-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217174-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217174-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217174-002	AP	1	`011fe1cb6892…`
2025-08-23 18:47 UTC	2025-08	A217174-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217174-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217174-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217174-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217174-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217174-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217174-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217174-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217174-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217174-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217174-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217174-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217174-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217174-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217174-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217174-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217174-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217174-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217174-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217174-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217174-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217174-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217174-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217174-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217174-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217174-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217174-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217174-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217174-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217174-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217174-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217174-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217174-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217174-002	AP	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217174-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217174-002	AP	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217174-001	CGT	2024-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217174-002	CGT	2024-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217174-001	CGT	2024-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217174-002	CGT	2024-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217174-001	CGT	2024-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217174-002	CGT	2024-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217174-001	CGT	2024-03-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217174-002	CGT	2024-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217174-001	CGT	2024-03-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217174-002	CGT	2024-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217174-001	CGT	2024-03-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217174-002	CGT	2024-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217174-001	CGT	2024-03-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217174-002	CGT	2024-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217174-001	CGT	2024-03-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217174-002	CGT	2024-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217174-001	CGT	2024-03-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217174-002	CGT	2024-03-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217174-001	CGT	2024-03-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217174-002	CGT	2024-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217174-001	CGT	2024-03-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217174-002	CGT	2024-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217174-001	CGT	2024-03-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217174-002	CGT	2024-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217174-001	CGT	2024-03-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217174-002	CGT	2024-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217174-001	CGT	2024-03-10	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217174-002	CGT	2024-03-10	`9b2671bbb829…`

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	20 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2117608	Internal RxNorm lookup
2117610	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
8ee79b4c-21d3-4742-ae37-e2f562917706	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
80830-2363-2	CALCIUM GLUCONATE	1 in 1 POUCH	INJECTION, SOLUTION	1	16
80830-2363-2	CALCIUM GLUCONATE	12 in 1 CARTON	INJECTION, SOLUTION	12	16
80830-2363-9	CALCIUM GLUCONATE	24 in 1 CARTON	INJECTION, SOLUTION	24	16
80830-2363-9	CALCIUM GLUCONATE	1 in 1 POUCH	INJECTION, SOLUTION	1	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80830-2363-1	ML - Milliliter	80830-2363	c280cfda-f4cd-49e5-aa82-370851426c8e	1	2023-10-16
80830-2363-2	ML - Milliliter	80830-2363	f282305d-852a-44ed-953e-ae8bf25051cb	1	2024-02-14
80830-2363-9	ML - Milliliter	80830-2363	e615c832-cfac-41c6-896f-7114bba7504e	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80830-2363	CALCIUM GLUCONATE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED]	16	Current NDC, 4 package rows	20250522_8ee79b4c-21d3-4742-ae37-e2f562917706.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CALCIUM GLUCONATE	CALCIUM GLUCONATE	Amneal Pharmaceuticals Private Limited	8ee79b4c-21d3-4742-ae37-e2f562917706	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217174 application number: ANDA217174 ndc (product): 80830-2363

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
2117610	calcium gluconate 1000 MG in 50 mL Injection	PSN	8ee79b4c-21d3-4742-ae37-e2f562917706	16
2117608	calcium gluconate 2000 MG in 100 ML Injection	PSN	8ee79b4c-21d3-4742-ae37-e2f562917706	16
2117608	100 ML calcium gluconate 20 MG/ML Injection	SCD	8ee79b4c-21d3-4742-ae37-e2f562917706	16
2117610	50 ML calcium gluconate 20 MG/ML Injection	SCD	8ee79b4c-21d3-4742-ae37-e2f562917706	16
2117610	calcium gluconate 1000 MG per 50 ML Injection	SY	8ee79b4c-21d3-4742-ae37-e2f562917706	16
2117608	calcium gluconate 2000 MG per 100 ML Injection	SY	8ee79b4c-21d3-4742-ae37-e2f562917706	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80830-2363-2	80830236302	12 POUCH in 1 CARTON (80830-2363-2) / 1 BAG in 1 POUCH / 100 mL in 1 BAG	12 pouch	2023-11-08	No	No	Current
80830-2363-9	80830236309	24 POUCH in 1 CARTON (80830-2363-9) / 1 BAG in 1 POUCH / 100 mL in 1 BAG	24 pouch	2023-09-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CALCIUM GLUCONATE	Amneal Pharmaceuticals Private Limited	2024-04-18	HUMAN PRESCRIPTION DRUG LABEL	16