Home NDC 0264-5600 Calcium Gluconate
Product NDC 0264-5600
11-digit product format 002645600
Labeler code 0264
Product ID 0264-5600_c39effaa-a9b8-4430-a42a-c642b76550df
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcium Gluconate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler B. Braun Medical Inc.
Application ANDA216541
Marketing category ANDA
Marketing start 2023-11-02
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216541-001 CALCIUM GLUCONATE CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216541-001 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.
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 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216541-001 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-08-21 a50c72e98297…
Observed Orange Book normalized TE history# 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 A216541-001 CGT 2024-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216541-001 CGT 2024-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216541-001 CGT 2024-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216541-001 CGT 2024-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216541-001 CGT 2024-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216541-001 CGT 2024-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216541-001 CGT 2024-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216541-001 CGT 2024-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216541-001 CGT 2024-04-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216541-001 CGT 2024-04-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216541-001 CGT 2024-04-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216541-001 CGT 2024-04-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216541-001 CGT 2024-04-30 a72a2bbeb626…
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 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 0264-5600-52 Calcium Gluconate 100 mL in 1 CONTAINER INJECTION, SOLUTION 100 5 0264-5600-52 Calcium Gluconate 24 in 1 CASE INJECTION, SOLUTION 24 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-5600 CALCIUM GLUCONATE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.] 5 Current NDC, 2 package rows 20231104_af362bcb-7010-4eb5-b8c4-42aa3b0cdcde.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0264-5600-52 00264560052 24 CONTAINER in 1 CASE (0264-5600-52) / 100 mL in 1 CONTAINER 24 container 2023-11-02 No No Current