Home NDC 72658-1879 calcium chloride
Product NDC 72658-1879
11-digit product format 726581879
Labeler code 72658
Product ID 72658-1879_5b0baf5c-9c42-fe55-e063-6294a90a591a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcium chloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Eskayef Pharmaceuticals Limited
Application ANDA217463
Marketing category ANDA
Marketing start 2026-09-10
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 44 .
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 2026-10-15 13:18:30 2026-09 A217463-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2025-09-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217463-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2025-09-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217463-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2025-09-29 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
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 72658-1879-2 72658187902 10 VIAL in 1 BOX (72658-1879-2) / 10 mL in 1 VIAL (72658-1879-1) 10 vial 2026-09-10 No No Current