Home NDC 80830-1672 calcium gluconate
Product NDC 80830-1672
11-digit product format 808301672
Labeler code 80830
Product ID 80830-1672_eefdd45b-6407-4e69-b285-cd5b09d8dbdd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcium gluconate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals Private Limited
Application ANDA216611
Marketing category ANDA
Marketing start 2024-05-13
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 A216611-001 CALCIUM GLUCONATE CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 A216611-002 CALCIUM GLUCONATE CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 A216611-003 CALCIUM GLUCONATE CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10
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 · 45 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 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216611-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216611-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216611-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216611-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216611-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216611-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216611-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216611-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216611-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216611-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216611-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216611-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216611-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216611-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216611-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216611-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216611-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216611-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216611-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216611-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216611-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216611-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216611-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216611-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216611-002 CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216611-003 CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216611-001 CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS AP 2024-05-10 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 observed states.
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 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197435 Internal RxNorm lookup 1668248 Internal RxNorm lookup 1668250 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 80830-1672-1 calcium gluconate 10 mL in 1 VIAL INJECTION 10 3 80830-1672-2 calcium gluconate 10 in 1 CARTON INJECTION 10 3 80830-1672-5 calcium gluconate 25 in 1 CARTON INJECTION 25 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80830-1672 CALCIUM GLUCONATE INJECTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED] 3 Current NDC, 3 package rows 20240513_13d7cfc9-ff7a-437e-8c21-d9709ac07d48.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80830-1672-1 80830167201 10 mL in 1 VIAL 10 ml Historical 80830-1672-2 80830167202 10 VIAL in 1 CARTON (80830-1672-2) / 10 mL in 1 VIAL (80830-1672-1) 10 vial 2024-05-13 No No Current 80830-1672-4 80830167204 10 VIAL in 1 CARTON (80830-1672-4) / 10 mL in 1 VIAL 10 vial 2026-04-13 0 Current 80830-1672-5 80830167205 25 VIAL in 1 CARTON (80830-1672-5) / 10 mL in 1 VIAL (80830-1672-1) 25 vial 2024-05-13 No No Current