Calcium Acetate

Product NDC: 17856-0191
Requested package NDC: 17856-0191-1
11-digit product format: 178560191
Labeler code: 17856
Product ID: 17856-0191_89c965e4-6d61-4ca3-8242-a5b75532df05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcium Acetate
Dosage form: CAPSULE
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
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],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17856-0191	17856-0191-1	I	Inactivated by FDA		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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
A091312-001	CALCIUM ACETATE	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2012-06-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091312-001	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	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091312-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2012-06-01	`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	A091312-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091312-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091312-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091312-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091312-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091312-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091312-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091312-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091312-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091312-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091312-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091312-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091312-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091312-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091312-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091312-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091312-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091312-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091312-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091312-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091312-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091312-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091312-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091312-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091312-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091312-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091312-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091312-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091312-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091312-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091312-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091312-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091312-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091312-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091312-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091312-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091312-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091312-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091312-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091312-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-0191-1	2022-01-28	C162847	48780-1	d6a99b39-da16-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use CALCIUM ACETATE CAPSULES safely and effectively. See full prescribing information for CALCIUM ACETATE CAPSULES. CALCIUM ACETATE Capsules, for oral use Initial U.S. Approval: 1990

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-0191-1	Calcium Acetate	1 in 1 POUCH	CAPSULE	1		1
17856-0191-1	Calcium Acetate	100 in 1 BOX	CAPSULE	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0191	CALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORP.]	1	Legacy NDC, 2 package rows	20200527_489f35f6-28a4-47dc-8abf-6ce403afa9cc.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcium Acetate	CALCIUM ACETATE	Chartwell RX, LLC.	781c3f1f-b622-418b-8c0e-3407e9b90656	2023-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091312 application number: ANDA091312

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
359296	calcium acetate 667 MG (Ca 169 MG) Oral Capsule	PSN	489f35f6-28a4-47dc-8abf-6ce403afa9cc	1
359296	calcium acetate 667 MG Oral Capsule	SCD	489f35f6-28a4-47dc-8abf-6ce403afa9cc	1
359296	calcium acetate 667 MG (calcium 169 MG) Oral Capsule	SY	489f35f6-28a4-47dc-8abf-6ce403afa9cc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0191-1	17856019101	100 POUCH in 1 BOX (17856-0191-1) > 1 CAPSULE in 1 POUCH	100 pouch	2020-05-26	0000-00-00	No	No	Current