Home NDC 70121-2308 calcium chloride
Product NDC 70121-2308
11-digit product format 701212308
Labeler code 70121
Product ID 70121-2308_333cd3a6-c12b-48a2-ab6c-9b24a8c2e833
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcium chloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals LLC
Application ANDA217524
Marketing category ANDA
Marketing start 2024-07-17
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 A217524-001 CALCIUM CHLORIDE 10% CALCIUM CHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217524-001 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 A217524-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2024-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217524-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2024-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217524-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2024-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217524-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2024-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217524-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2024-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217524-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2024-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217524-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2024-07-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217524-001 CALCIUM CHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217524-001 CALCIUM CHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217524-001 CALCIUM CHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217524-001 CALCIUM CHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217524-001 CALCIUM CHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-08 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217524-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2024-07-08 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 828525 Internal RxNorm lookup 828527 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 70121-2308-1 calcium chloride 10 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 10 11 70121-2308-1 calcium chloride 1 in 1 CARTON INJECTION, SOLUTION 1 11 70121-2308-4 calcium chloride 24 in 1 CARTON INJECTION, SOLUTION 24 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70121-2308 CALCIUM CHLORIDE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC] 9 Current NDC, 3 package rows 20240825_7649c84f-f1c2-4169-962d-ccbac56523a9.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 70121-2308-1 70121230801 10 mL in 1 SYRINGE, GLASS 10 ml Historical 70121-2308-4 70121230804 24 CARTON in 1 CARTON (70121-2308-4) / 1 SYRINGE, GLASS in 1 CARTON (70121-2308-1) / 10 mL in 1 SYRINGE, GLASS 24 carton 2024-07-17 No No Current