Calcium Acetate

Product NDC: 0904-7119
11-digit product format: 009047119
Labeler code: 0904
Product ID: 0904-7119_ff2e23f6-ba35-4bb1-80ef-feba4ae00bc2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcium Acetate
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA077728
Marketing category: ANDA
Marketing start: 2008-02-26
Substance: CALCIUM ACETATE
Active strength: 667 mg/1
Pharmacologic classes: Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Calcium Acetate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CALCIUM ACETATE	667 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Y882YXF34X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
359296	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9a731cdf-6488-44ca-b97f-512a0e9deab1	Available on FDA.report

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-7119-06	Calcium Acetate	1 in 1 BLISTER PACK	CAPSULE	1	5
0904-7119-06	Calcium Acetate	50 in 1 CARTON	CAPSULE	50	5
0904-7119-61	Calcium Acetate	100 in 1 CARTON	CAPSULE	100	5
0904-7119-61	Calcium Acetate	1 in 1 BLISTER PACK	CAPSULE	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7119-06	EA - Each	0904-7119	fda6f9e2-432a-4409-9d8b-d57baa007b81	1	2021-07-15
0904-7119-61	EA - Each	0904-7119	ecacc097-26a2-4e1d-ae4a-a6f0799bfc5e	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7119	CALCIUM ACETATE CAPSULE [MAJOR PHARMACEUTICALS]	3	Current NDC, Legacy NDC, 4 package rows	20250101_9a731cdf-6488-44ca-b97f-512a0e9deab1.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 · 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 ndc (product): 0904-7119
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

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	9a731cdf-6488-44ca-b97f-512a0e9deab1	5
359296	calcium acetate 667 MG (Ca 169 MG) Oral Capsule	PSN	a23b6070-eb4b-48e3-b563-8232206a6be4	5
359296	calcium acetate 667 MG Oral Capsule	SCD	9a731cdf-6488-44ca-b97f-512a0e9deab1	5
359296	calcium acetate 667 MG Oral Capsule	SCD	a23b6070-eb4b-48e3-b563-8232206a6be4	5
359296	calcium acetate 667 MG (calcium 169 MG) Oral Capsule	SY	9a731cdf-6488-44ca-b97f-512a0e9deab1	5
359296	calcium acetate 667 MG (calcium 169 MG) Oral Capsule	SY	a23b6070-eb4b-48e3-b563-8232206a6be4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7119-06	00904711906	50 BLISTER PACK in 1 CARTON (0904-7119-06) / 1 CAPSULE in 1 BLISTER PACK	50 blister pack	2008-02-26	0000-00-00	No	No	Current
0904-7119-61	00904711961	100 BLISTER PACK in 1 CARTON (0904-7119-61) / 1 CAPSULE in 1 BLISTER PACK	100 blister pack	2008-02-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Calcium Acetate	Cardinal Health 107, LLC	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	5
Calcium Acetate	Major Pharmaceuticals	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	5