Home NDC 76483-108 calcium chloride
Product NDC 76483-108
11-digit product format 764830108
Labeler code 76483
Product ID 76483-108_e0f2dac8-19e2-4090-b520-c81b971c8598
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcium chloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler SQUARE PHARMACEUTICALS PLC.
Application ANDA217463
Marketing category ANDA
Marketing start 2026-01-15
Substance CALCIUM CHLORIDE
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 1 .
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 A217463-001 CALCIUM CHLORIDE 10% CALCIUM CHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2025-09-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217463-001 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 2026-02-19 14:30 UTC 2026-02 A217463-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2025-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217463-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2025-09-29 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217463-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2025-09-29 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217463-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217463-001 AP 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217463-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base calcium chloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CHLORIDE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M4I0D6VV5M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 828525 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 76483-108-01 calcium chloride 10 mL in 1 VIAL INJECTION, SOLUTION 10 3 76483-108-02 calcium chloride 10 in 1 BOX INJECTION, SOLUTION 10 3
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 76483-108-01 76483010801 10 mL in 1 VIAL 10 ml Historical 76483-108-02 76483010802 10 VIAL in 1 BOX (76483-108-02) / 10 mL in 1 VIAL (76483-108-01) 10 vial 2026-01-15 No No Current