Calcium Chloride

Product NDC
76329-3304
11-digit product format
763293304
Labeler code
76329
Product ID
76329-3304_fe9c2714-4299-4327-96cd-cf3ab03efcde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Chloride
Dosage form
INJECTION
Route
INTRAVENOUS; INTRAVENTRICULAR
Labeler
International Medication Systems, Limited
Application
ANDA203477
Marketing category
ANDA
Marketing start
2018-07-08
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203477-001CALCIUM CHLORIDE 10%CALCIUM CHLORIDE100MG/MLINJECTABLE / INJECTIONAP2018-05-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A203477-001AP

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-093f01610625f2…
2019-09-15 20:21 UTC2019-09A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203477-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203477-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203477-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203477-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203477-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203477-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203477-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203477-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203477-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203477-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203477-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203477-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203477-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203477-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203477-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203477-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203477-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203477-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203477-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203477-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203477-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A203477-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203477-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203477-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203477-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A203477-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203477-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203477-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203477-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203477-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203477-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203477-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203477-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203477-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203477-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203477-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203477-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203477-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203477-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203477-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Calcium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CHLORIDE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M4I0D6VV5MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
828527Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8295039b-2559-4626-90c8-6ac7e896e41aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76329-3304-1Calcium Chloride10 in 1 PACKAGEINJECTION109
76329-3304-1Calcium Chloride10 mL in 1 SYRINGEINJECTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76329-3304-1ML - Milliliter76329-330465d97f45-431e-4b7a-98cc-29afd8b898c212013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-3304CALCIUM CHLORIDE (CALCIUM CHLORIDE ) INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]8Current NDC, Legacy NDC, 2 package rows20230708_8295039b-2559-4626-90c8-6ac7e896e41a.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium ChlorideCALCIUM CHLORIDEREMEDYREPACK INC.801f110c-7800-4689-a37a-f31d99c0f9302025-09-29Adverse reactionsExact identifier
application applno (ANDA): 203477
application number: ANDA203477
Calcium ChlorideCALCIUM CHLORIDEProPharma Distribution3eef0115-26f6-2abe-e063-6294a90aa2892025-09-16Adverse reactionsExact identifier
application applno (ANDA): 203477
application number: ANDA203477
Calcium ChlorideCALCIUM CHLORIDEInternational Medication Systems, Limited8295039b-2559-4626-90c8-6ac7e896e41a2024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203477
application number: ANDA203477
ndc (product): 76329-3304
CALCIUM CHLORIDECALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst994a17da-4430-9489-e053-2a95a90acb7c2024-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203477
application number: ANDA203477

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828527calcium chloride 10 % in 10 ML Prefilled SyringePSN8295039b-2559-4626-90c8-6ac7e896e41a9
82852710 ML calcium chloride 100 MG/ML Prefilled SyringeSCD8295039b-2559-4626-90c8-6ac7e896e41a9
828527calcium chloride 10 % in 10 ML Prefilled SyringeSY8295039b-2559-4626-90c8-6ac7e896e41a9
828527calcium chloride 10 % in 10 ML Prefilled SyringePSN994a17da-4430-9489-e053-2a95a90acb7c5
82852710 ML calcium chloride 100 MG/ML Prefilled SyringeSCD994a17da-4430-9489-e053-2a95a90acb7c5
828527calcium chloride 10 % in 10 ML Prefilled SyringeSY994a17da-4430-9489-e053-2a95a90acb7c5
828527calcium chloride 10 % in 10 ML Prefilled SyringePSN6b15706b-199c-beba-e053-2991aa0a17343
828527calcium chloride 10 % in 10 ML Prefilled SyringePSN801f110c-7800-4689-a37a-f31d99c0f9303
82852710 ML calcium chloride 100 MG/ML Prefilled SyringeSCD6b15706b-199c-beba-e053-2991aa0a17343
82852710 ML calcium chloride 100 MG/ML Prefilled SyringeSCD801f110c-7800-4689-a37a-f31d99c0f9303
828527calcium chloride 10 % in 10 ML Prefilled SyringeSY6b15706b-199c-beba-e053-2991aa0a17343
828527calcium chloride 10 % in 10 ML Prefilled SyringeSY801f110c-7800-4689-a37a-f31d99c0f9303
828527calcium chloride 10 % in 10 ML Prefilled SyringePSN3eef0115-26f6-2abe-e063-6294a90aa2891
82852710 ML calcium chloride 100 MG/ML Prefilled SyringeSCD3eef0115-26f6-2abe-e063-6294a90aa2891
828527calcium chloride 10 % in 10 ML Prefilled SyringeSY3eef0115-26f6-2abe-e063-6294a90aa2891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76329-3304-17632933040110 SYRINGE in 1 PACKAGE (76329-3304-1) / 10 mL in 1 SYRINGE10 syringe2018-07-080000-00-00NoNoCurrent