Calcium Acetate

Product NDC: 55154-4984
11-digit product format: 551544984
Labeler code: 55154
Product ID: 55154-4984_dac1071a-100c-4bcc-afcd-c0f2f8da2d58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcium Acetate
Dosage form: CAPSULE
Route: ORAL
Labeler: Cardinal Health
Application: ANDA077728
Marketing category: ANDA
Marketing start: 2013-07-26
Marketing end: 2021-06-30
Substance: CALCIUM ACETATE
Active strength: 667 mg/1
Pharmacologic classes: Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55154-4984		D	Discontinued by firm		2026-08-17
excluded package	package	55154-4984	55154-4984-0	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-4984-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-4984-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55154-4984-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55154-4984-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55154-4984-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55154-4984-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55154-4984-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55154-4984-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55154-4984-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-4984-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55154-4984-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55154-4984-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A077728-001	CALCIUM ACETATE	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2008-02-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077728-001	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077728-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2008-02-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077728-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077728-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077728-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077728-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077728-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077728-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077728-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077728-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077728-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077728-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077728-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077728-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077728-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077728-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077728-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077728-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077728-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077728-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077728-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077728-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077728-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077728-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077728-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077728-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077728-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077728-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077728-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077728-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077728-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077728-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077728-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077728-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077728-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077728-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077728-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077728-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077728-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077728-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077728-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077728-001	AB	1	`e64feba35796…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCIUM ACETATE	ACTIVE INGREDIENT	Y882YXF34X	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CALCIUM ACETATE CAPSULE [CARDINAL HEALTH]	2

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcium Acetate	CALCIUM ACETATE	Cardinal Health 107, LLC	a23b6070-eb4b-48e3-b563-8232206a6be4	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077728 application number: ANDA077728
Calcium Acetate	CALCIUM ACETATE	Major Pharmaceuticals	9a731cdf-6488-44ca-b97f-512a0e9deab1	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077728 application number: ANDA077728
Calcium Acetate	CALCIUM ACETATE	American Health Packaging	1090762c-eec1-4ab0-9ddc-43caa764cd0e	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077728 application number: ANDA077728
Calcium Acetate	CALCIUM ACETATE	Hikma Pharmaceuticals USA Inc.	85fd41f8-2823-44ca-a15e-f1f2e5d0ff94	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077728 application number: ANDA077728

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y882YXF34X	CALCIUM ACETATE	62-54-4	CALCIUM ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-4984-0	55154498400	10 BLISTER PACK in 1 BAG (55154-4984-0) > 1 CAPSULE in 1 BLISTER PACK	10 blister pack	2013-07-26	2021-06-30	No	No	Current