calcium gluconate

Product NDC
75834-171
Requested package NDC
75834-171-19
11-digit product format
758340171
Labeler code
75834
Product ID
75834-171_b99af4e6-74c3-4a4f-85f2-6dcc0a759449
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcium gluconate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA213071
Marketing category
ANDA
Marketing start
2022-10-24
Marketing end
0000-00-00
Substance
CALCIUM GLUCONATE MONOHYDRATE
Active strength
98 mg/mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage75834-17175834-171-19IInactivated by FDA2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213071-001CALCIUM GLUCONATECALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-14
A213071-002CALCIUM GLUCONATECALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-19
A213071-003CALCIUM GLUCONATECALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A213071-001AP
A213071-002AP
A213071-003AP

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 · 62 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-14caaa826d4ba7…
2026-08-18 06:07:402026-07A213071-002CALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A213071-003CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213071-002CALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213071-003CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213071-002CALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213071-003CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213071-002CALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213071-003CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213071-002CALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213071-003CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213071-002CALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213071-003CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213071-002CALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213071-003CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213071-002CALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213071-003CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213071-002CALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213071-003CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213071-002CALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213071-003CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A213071-002CALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A213071-003CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213071-002CALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213071-003CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213071-002CALCIUM GLUCONATE5GM/50ML (100MG/ML)SOLUTION / INTRAVENOUSAP2023-10-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213071-003CALCIUM GLUCONATE10GM/100ML (100MG/ML)SOLUTION / INTRAVENOUSAP2024-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213071-001CALCIUM GLUCONATE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSAP2022-10-141e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213071-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A213071-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A213071-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213071-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213071-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213071-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213071-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213071-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213071-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213071-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213071-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213071-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213071-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213071-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213071-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213071-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213071-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213071-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213071-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213071-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213071-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213071-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213071-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213071-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213071-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213071-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213071-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213071-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213071-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213071-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213071-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213071-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213071-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213071-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213071-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213071-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213071-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213071-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213071-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213071-001AP11e350fbaab3a…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2023-12-20 04:57 UTC2023-12A213071-001CGT2023-05-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213071-001CGT2023-05-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213071-001CGT2023-05-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213071-001CGT2023-05-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213071-001CGT2023-05-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A213071-001CGT2023-05-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A213071-001CGT2023-05-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213071-001CGT2023-05-053a93d1ddd44b…

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
75834-171-01calcium gluconate10 mL in 1 VIALINJECTION, SOLUTION103
75834-171-19calcium gluconate25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-171-01ML - Milliliter75834-171cb06d12e-798d-4c8c-baee-af6f763e3b3912022-12-07
75834-171-19ML - Milliliter75834-171599e8018-0a9e-42c3-a445-1843728a44ca12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-171CALCIUM GLUCONATE INJECTION, SOLUTION [NIVAGEN PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20221024_0522051a-d044-4cee-acbc-378a607b4855.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium GluconateCALCIUM GLUCONATEHenry Schein, Inc.3cbf6bf7-2415-4435-b3df-41855514a05d2025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213071
application number: ANDA213071
calcium gluconateCALCIUM GLUCONATEREMEDYREPACK INC.d6db3a1c-ed02-48fc-9134-ea1d58acf42e2025-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213071
application number: ANDA213071
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.8ec4d137-1e9b-40e2-aeb2-8f62626a8fa52023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213071
application number: ANDA213071
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.ce7becd8-cf59-4470-aac8-82761a24ebd72023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213071
application number: ANDA213071
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.313a4ea9-178b-495e-9bc7-af1860fa65012023-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213071
application number: ANDA213071

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1668250calcium gluconate 1 GM in 10 ML (10 % ) InjectionPSN0522051a-d044-4cee-acbc-378a607b48553
166825010 ML calcium gluconate 100 MG/ML InjectionSCD0522051a-d044-4cee-acbc-378a607b48553
1668250calcium gluconate 10 % per 10 ML InjectionSY0522051a-d044-4cee-acbc-378a607b48553

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-171-197583401711925 VIAL in 1 CARTON (75834-171-19) > 10 mL in 1 VIAL (75834-171-01) 25 vial2022-10-240000-00-00NoNoCurrent