Calcium Acetate

Product NDC: 0904-6546
11-digit product format: 009046546
Labeler code: 0904
Product ID: 0904-6546_c2e4a67f-0550-4604-b8d3-a5614a5ef01e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcium Acetate
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA201658
Marketing category: ANDA
Marketing start: 2014-10-08
Marketing end: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0904-6546		D	Discontinued by firm	2026-08-17
excluded package	package	0904-6546	0904-6546-06	D	Discontinued by firm	2026-08-17
excluded package	package	0904-6546	0904-6546-61	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 · 36 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	0904-6546-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-6546-06	`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	0904-6546-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-6546-06	`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	0904-6546-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-6546-06	`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	0904-6546-61	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-6546-06	`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	0904-6546-61	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-6546-06	`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	0904-6546-61	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-6546-06	`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	0904-6546-61	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-6546-06	`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	0904-6546-61	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0904-6546-06	`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	0904-6546-61	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0904-6546-06	`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	0904-6546-61	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0904-6546-06	`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	0904-6546-61	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0904-6546-06	`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	0904-6546-61	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0904-6546-06	`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
A201658-001	CALCIUM ACETATE	CALCIUM ACETATE	667MG	CAPSULE / ORAL			2014-10-06

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	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2014-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201658-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2014-10-06	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201658-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201658-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201658-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201658-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201658-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201658-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201658-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201658-001	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6546-06	EA - Each	0904-6546	2096950b-f96b-4620-8dc5-32b0ef3d0861	1	2018-01-12
0904-6546-61	EA - Each	0904-6546	2c8b27ff-7a56-4464-b1be-1616c9b5ee56	1	2016-10-06

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcium Acetate	CALCIUM ACETATE	Amneal Pharmaceuticals of New York LLC	4a490e1d-80ee-461f-aba6-01f54fe8a5fe	2020-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201658 application number: ANDA201658

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Calcium Acetate	Major Pharmaceuticals	2020-12-02	HUMAN PRESCRIPTION DRUG LABEL	4
Calcium Acetate	Cardinal Health	2020-05-26	HUMAN PRESCRIPTION DRUG LABEL	2