Home NDC 70069-728 CALCIUM GLUCONATE
Product NDC 70069-728
11-digit product format 700690728
Labeler code 70069
Product ID 70069-728_42dd49af-172b-4202-ab5c-442fa942a491
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CALCIUM GLUCONATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Somerset Therapeutics, LLC
Application ANDA217689
Marketing category ANDA
Marketing start 2023-10-20
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217689-001 CALCIUM GLUCONATE CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 A217689-002 CALCIUM GLUCONATE CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A217689-001 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217689-001 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217689-001 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 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217689-001 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217689-001 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 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217689-001 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 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217689-001 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 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217689-001 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 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217689-001 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 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217689-001 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 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217689-001 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217689-001 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 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217689-001 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 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217689-001 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217689-001 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217689-001 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217689-001 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217689-001 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217689-001 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217689-001 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217689-002 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 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 A217689-001 CGT 2024-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217689-001 CGT 2024-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217689-001 CGT 2024-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217689-001 CGT 2024-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217689-001 CGT 2024-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217689-001 CGT 2024-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217689-001 CGT 2024-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217689-001 CGT 2024-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217689-001 CGT 2024-04-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217689-001 CGT 2024-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217689-001 CGT 2024-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217689-001 CGT 2024-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217689-001 CGT 2024-04-17 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197435 Internal RxNorm lookup 1668248 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 70069-728-01 CALCIUM GLUCONATE 100 mL in 1 VIAL, PLASTIC INJECTION, SOLUTION 100 6 70069-728-10 CALCIUM GLUCONATE 10 in 1 CARTON INJECTION, SOLUTION 10 6 70069-728-10 CALCIUM GLUCONATE 100 mL in 1 VIAL, PLASTIC INJECTION, SOLUTION 100 6 70069-728-20 CALCIUM GLUCONATE 20 in 1 CARTON INJECTION, SOLUTION 20 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-728 CALCIUM GLUCONATE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] 6 Current NDC, 4 package rows 20250209_fb40eba7-04e5-40dc-8a95-5f45e7bd70bc.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70069-728-01 70069072801 100 mL in 1 VIAL, PLASTIC 100 ml Historical 70069-728-10 70069072810 10 VIAL, PLASTIC in 1 CARTON (70069-728-10) / 100 mL in 1 VIAL, PLASTIC 2024-03-27 No No Current 70069-728-20 70069072820 20 VIAL, PLASTIC in 1 CARTON (70069-728-20) / 100 mL in 1 VIAL, PLASTIC (70069-728-01) 2023-10-20 No No Current