Calcium Chloride

Product NDC: 70518-4734
11-digit product format: 705184734
Labeler code: 70518
Product ID: 70518-4734_59f29224-1055-e6c8-e063-6394a90aed2b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcium Chloride Injection
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: REMEDYREPACK INC.
Application: ANDA211553
Marketing category: ANDA
Marketing start: 2026-08-25
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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211553-001	CALCIUM CHLORIDE 10%	100MG/ML	INJECTABLE / INJECTION	AP	2019-05-01	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211553-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211553-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211553-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211553-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211553-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211553-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211553-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211553-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211553-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211553-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211553-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211553-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211553-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211553-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211553-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211553-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211553-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211553-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211553-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211553-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211553-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211553-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211553-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211553-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211553-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211553-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211553-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211553-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211553-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211553-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211553-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211553-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211553-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211553-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211553-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211553-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211553-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211553-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211553-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211553-001	AP	1	`f41ea6bd6efb…`

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
828527	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3089499b-142d-482e-889d-1db4da7b1152	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcium Chloride	CALCIUM CHLORIDE INJECTION	REMEDYREPACK INC.	3089499b-142d-482e-889d-1db4da7b1152	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211553 application number: ANDA211553 ndc (product): 70518-4734
Calcium Chloride	CALCIUM CHLORIDE INJECTION	Medefil, Inc.	90b8936e-61f2-5318-e053-2995a90aac44	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211553 application number: ANDA211553
Calcium Chloride	CALCIUM CHLORIDE INJECTION	Medical Purchasing Solutions, LLC	9e502cf2-3f4d-13ec-e053-2a95a90a970e	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211553 application number: ANDA211553

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M4I0D6VV5M	CALCIUM CHLORIDE	10035-04-8	CALCIUM CHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4734-0	70518473400	10 SYRINGE, PLASTIC in 1 BOX (70518-4734-0) / 10 mL in 1 SYRINGE, PLASTIC (70518-4734-1)	2026-08-25	No	No	Current