Home NDC 44567-623 Calcium Gluconate
Product NDC 44567-623
11-digit product format 445670623
Labeler code 44567
Product ID 44567-623_42513ad1-fef6-4fc6-8cdd-df0f4a56eb0f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcium Gluconate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler WG Critical Care, LLC
Application NDA210906
Marketing category NDA
Marketing start 2018-10-26
Substance CALCIUM GLUCONATE
Active strength 100 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 2027-12-31
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE CALCIUM GLUCONATE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE CALCIUM GLUCONATE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE CALCIUM GLUCONATE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 N210906-004 CALCIUM GLUCONATE CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-11-18
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210906-001 10130646 2037-07-25 Drug product 2018-11-20 N210906-001 10342813 2037-07-25 Drug product 2019-07-31 N210906-002 10130646 2037-07-25 Drug product 2018-11-20 N210906-002 10342813 2037-07-25 Drug product 2019-07-31 N210906-003 10130646 2037-07-25 Drug product 2021-10-15 N210906-003 10342813 2037-07-25 Drug product 2021-10-15
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 3 · 120 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 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210906-004 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-11-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 301d65b070ca…
Observed Orange Book patent history# Patent history page 1 of 6 · 234 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N210906-001 10130646 2037-07-25 Drug product 2018-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210906-001 10342813 2037-07-25 Drug product 2019-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210906-002 10130646 2037-07-25 Drug product 2018-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210906-002 10342813 2037-07-25 Drug product 2019-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210906-003 10130646 2037-07-25 Drug product 2021-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210906-003 10342813 2037-07-25 Drug product 2021-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210906-001 10130646 2037-07-25 Drug product 2018-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210906-001 10342813 2037-07-25 Drug product 2019-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210906-002 10130646 2037-07-25 Drug product 2018-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210906-002 10342813 2037-07-25 Drug product 2019-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210906-003 10130646 2037-07-25 Drug product 2021-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210906-003 10342813 2037-07-25 Drug product 2021-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210906-001 10130646 2037-07-25 Drug product 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210906-001 10342813 2037-07-25 Drug product 2019-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210906-002 10130646 2037-07-25 Drug product 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210906-002 10342813 2037-07-25 Drug product 2019-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210906-003 10130646 2037-07-25 Drug product 2021-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210906-003 10342813 2037-07-25 Drug product 2021-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210906-001 10130646 2037-07-25 Drug product 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210906-001 10342813 2037-07-25 Drug product 2019-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210906-002 10130646 2037-07-25 Drug product 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210906-002 10342813 2037-07-25 Drug product 2019-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210906-003 10130646 2037-07-25 Drug product 2021-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210906-003 10342813 2037-07-25 Drug product 2021-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210906-001 10130646 2037-07-25 Drug product 2018-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210906-001 10342813 2037-07-25 Drug product 2019-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210906-002 10130646 2037-07-25 Drug product 2018-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210906-002 10342813 2037-07-25 Drug product 2019-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210906-003 10130646 2037-07-25 Drug product 2021-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210906-003 10342813 2037-07-25 Drug product 2021-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210906-001 10130646 2037-07-25 Drug product 2018-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210906-001 10342813 2037-07-25 Drug product 2019-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210906-002 10130646 2037-07-25 Drug product 2018-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210906-002 10342813 2037-07-25 Drug product 2019-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210906-003 10130646 2037-07-25 Drug product 2021-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210906-003 10342813 2037-07-25 Drug product 2021-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210906-001 10130646 2037-07-25 Drug product 2018-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210906-001 10342813 2037-07-25 Drug product 2019-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210906-002 10130646 2037-07-25 Drug product 2018-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210906-002 10342813 2037-07-25 Drug product 2019-07-31 03ed91905a0d…
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 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SQE6VB453K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197435 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44567-623-01 Calcium Gluconate 100 mL in 1 BAG INJECTION, SOLUTION 100 3 44567-623-01 Calcium Gluconate 1 in 1 POUCH INJECTION, SOLUTION 1 3 44567-623-10 Calcium Gluconate 10 in 1 CARTON INJECTION, SOLUTION 10 3
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 44567-623-01 44567062301 100 mL in 1 BAG 100 ml Historical 44567-623-10 44567062310 10 POUCH in 1 CARTON (44567-623-10) / 1 BAG in 1 POUCH (44567-623-01) / 100 mL in 1 BAG 10 pouch 2026-01-01 No No Current