Calcium Acetate

Product NDC
68094-044
11-digit product format
680940044
Labeler code
68094
Product ID
68094-044_20816a35-ca8c-45fe-b785-1ca9f6abcc51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Acetate
Dosage form
CAPSULE
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA091312
Marketing category
ANDA
Marketing start
2018-06-29
Marketing end
0000-00-00
Substance
CALCIUM ACETATE
Active strength
667 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68094-044DDiscontinued by firm2026-08-10
excluded packagepackage68094-04468094-044-61DDiscontinued by firm2026-08-10

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
A091312-001CALCIUM ACETATECALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091312-001AB

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 UTC2026-02A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-013f01610625f2…
2019-09-15 20:21 UTC2019-09A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091312-001CALCIUM ACETATE667MGCAPSULE / ORALAB2012-06-01cb3db0bc1861…

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 UTC2026-02A091312-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091312-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091312-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091312-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091312-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091312-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091312-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091312-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091312-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091312-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091312-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091312-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091312-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091312-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091312-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091312-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091312-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091312-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091312-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091312-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091312-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091312-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091312-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091312-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091312-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091312-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091312-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091312-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091312-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091312-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091312-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091312-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091312-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091312-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091312-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091312-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091312-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091312-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091312-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091312-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-044-59EA - Each68094-0446fedf860-9a0a-4db8-98c4-ae16a576375c12022-06-06
68094-044-61EA - Each68094-0442508eae0-3365-4b15-9e26-1a0f274d85be12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-044CALCIUM ACETATE CAPSULE [PRECISION DOSE, INC.]2Legacy NDC20220521_18602acd-d31b-492c-9552-da7aeb0de428.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium AcetateCALCIUM ACETATEChartwell RX, LLC.781c3f1f-b622-418b-8c0e-3407e9b906562023-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091312
application number: ANDA091312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-044-616809400446110 BLISTER PACK in 1 CARTON (68094-044-61) > 10 CAPSULE in 1 BLISTER PACK (68094-044-59) 10 blister pack2022-05-060000-00-00NoNoCurrent