Home NDC 44567-623-10 Calcium Gluconate
Product NDC 44567-623
Requested package NDC 44567-623-10
11-digit product format 445670623
Labeler code 44567
Product ID 44567-623_62edfc55-5292-4d27-ba52-d72d34744ead
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 44 .
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 4 · 128 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 2026-10-15 13:18:30 2026-09 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210906-004 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-11-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 N210906-001 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/50ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210906-002 CALCIUM GLUCONATE IN SODIUM CHLORIDE 2GM/100ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210906-003 CALCIUM GLUCONATE IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210906-004 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-11-18 84e616aacf4f…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…
Observed Orange Book patent history# Patent history page 1 of 7 · 246 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N210906-001 10130646 2037-07-25 Drug product 2018-11-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210906-001 10342813 2037-07-25 Drug product 2019-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210906-002 10130646 2037-07-25 Drug product 2018-11-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210906-002 10342813 2037-07-25 Drug product 2019-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210906-003 10130646 2037-07-25 Drug product 2021-10-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210906-003 10342813 2037-07-25 Drug product 2021-10-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 N210906-001 10130646 2037-07-25 Drug product 2018-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210906-001 10342813 2037-07-25 Drug product 2019-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210906-002 10130646 2037-07-25 Drug product 2018-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210906-002 10342813 2037-07-25 Drug product 2019-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210906-003 10130646 2037-07-25 Drug product 2021-10-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210906-003 10342813 2037-07-25 Drug product 2021-10-15 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 44567-623-10 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