Home NDC 64253-900-91 Calcium Chloride
Product NDC 64253-900
Requested package NDC 64253-900-91
11-digit product format 642530900
Labeler code 64253
Product ID 64253-900_37c737b1-dc25-bcce-e063-6294a90a6f70
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcium Chloride Injection
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Medefil, Inc.
Application ANDA211553
Marketing category ANDA
Marketing start 2019-08-22
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 64253-900 64253-900-91 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 64253-900 64253-900-91 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A211553-001 CALCIUM CHLORIDE 10% CALCIUM CHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2019-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211553-001 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.
Product history page 1 of 2 · 42 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 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211553-001 CALCIUM CHLORIDE 10% 100MG/ML INJECTABLE / INJECTION AP 2019-05-01 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Calcium Chloride
Listing expiration 2026-12-31 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 828527 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64253-900-36 2022-06-27 These highlights do not include all the information needed to use 10% CALCIUM CHLORIDE INJECTION, USP safely and effectively. See full prescribing information for 10% CALCIUM CHLORIDE INJECTION, USP. 10% CALCIUM CHLORIDE INJECTION, USP for Intravenous Injection Initial U.S. Approval: 2019 64253-900-91 2022-06-27 These highlights do not include all the information needed to use 10% CALCIUM CHLORIDE INJECTION, USP safely and effectively. See full prescribing information for 10% CALCIUM CHLORIDE INJECTION, USP. 10% CALCIUM CHLORIDE INJECTION, USP for Intravenous Injection Initial U.S. Approval: 2019 64253-900-36 2022-01-28 These highlights do not include all the information needed to use 10% CALCIUM CHLORIDE INJECTION, USP safely and effectively. See full prescribing information for 10% CALCIUM CHLORIDE INJECTION, USP. 10% CALCIUM CHLORIDE INJECTION, USP for Intravenous Injection Initial U.S. Approval: 2019 64253-900-91 2022-01-28 These highlights do not include all the information needed to use 10% CALCIUM CHLORIDE INJECTION, USP safely and effectively. See full prescribing information for 10% CALCIUM CHLORIDE INJECTION, USP. 10% CALCIUM CHLORIDE INJECTION, USP for Intravenous Injection Initial U.S. Approval: 2019
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64253-900-30 Calcium Chloride 10 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 10 5 64253-900-36 Calcium Chloride 60 in 1 BOX INJECTION, SOLUTION 60 5 64253-900-91 Calcium Chloride 10 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 10 5 64253-900-91 Calcium Chloride 10 in 1 BOX INJECTION, SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64253-900 CALCIUM CHLORIDE (CALCIUM CHLORIDE INJECTION) INJECTION, SOLUTION [MEDEFIL, INC.] 4 Current NDC, Legacy NDC, 4 package rows 20230615_90b8936e-61f2-5318-e053-2995a90aac44.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64253-900-91 64253090091 10 SYRINGE, PLASTIC in 1 BOX (64253-900-91) / 10 mL in 1 SYRINGE, PLASTIC 2020-09-21 0000-00-00 No No Current