Home NDC 0143-9185 calcium gluconate
Product NDC 0143-9185
11-digit product format 001439185
Labeler code 0143
Product ID 0143-9185_8ec4d137-1e9b-40e2-aeb2-8f62626a8fa5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcium gluconate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA213071
Marketing category ANDA
Marketing start 2024-06-30
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213071-001 CALCIUM GLUCONATE CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 A213071-002 CALCIUM GLUCONATE CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 A213071-003 CALCIUM GLUCONATE CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
Product history page 1 of 2 · 62 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 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213071-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213071-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213071-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213071-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213071-002 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 A213071-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213071-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213071-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213071-002 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 A213071-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213071-002 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 A213071-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213071-002 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 A213071-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213071-002 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 A213071-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213071-002 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 A213071-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213071-002 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 A213071-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213071-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213071-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213071-002 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 A213071-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213071-002 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 A213071-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213071-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2022-10-14 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A213071-001 CGT 2023-05-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213071-001 CGT 2023-05-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213071-001 CGT 2023-05-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213071-001 CGT 2023-05-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213071-001 CGT 2023-05-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213071-001 CGT 2023-05-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213071-001 CGT 2023-05-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213071-001 CGT 2023-05-05 3a93d1ddd44b…
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 · 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 0143-9185-01 calcium gluconate 100 mL in 1 VIAL INJECTION, SOLUTION 100 1 0143-9185-20 calcium gluconate 20 in 1 CARTON INJECTION, SOLUTION 20 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9185 CALCIUM GLUCONATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 1 Current NDC, 2 package rows 20240630_8ec4d137-1e9b-40e2-aeb2-8f62626a8fa5.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 · 5 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 0143-9185-01 00143918501 100 mL in 1 VIAL 100 ml Historical 0143-9185-20 00143918520 20 VIAL in 1 CARTON (0143-9185-20) / 100 mL in 1 VIAL (0143-9185-01) 20 vial 2024-06-30 No No Current