Calcium Acetate

Product NDC: 72789-422
Requested package NDC: 72789-422-97
11-digit product format: 727890422
Labeler code: 72789
Product ID: 72789-422_4123b0e5-2fcd-88fb-e063-6294a90a05e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcium Acetate
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA217205
Marketing category: ANDA
Marketing start: 2023-12-07
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A217205-001	CALCIUM ACETATE	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB		2023-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217205-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2023-03-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2023-03-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL		2023-03-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217205-001	CALCIUM ACETATE	667MG	CAPSULE / ORAL	AB	2023-03-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217205-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217205-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217205-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217205-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217205-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217205-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217205-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217205-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217205-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217205-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217205-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217205-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217205-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217205-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217205-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217205-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217205-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217205-001	AB	1	`1c564ffb4f44…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217205-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217205-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A217205-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217205-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Calcium Acetate
Listing expiration: 2026-12-31

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
925918d5-9f89-4f2f-9bb9-d9c53d90bb0a	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	Strength	SPL version
72789-422-97	Calcium Acetate	200 in 1 BOTTLE, PLASTIC	CAPSULE	200		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-422-97	EA - Each	72789-422	db834e4d-bbfb-433c-8d36-c1d6388c7890	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-422	CALCIUM ACETATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	2	Current NDC, 1 package rows	20240717_925918d5-9f89-4f2f-9bb9-d9c53d90bb0a.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	NCS HealthCare of KY, LLC dba Vangard Labs	7177829c-bd89-485c-b5e3-15e457e969c5	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217205 application number: ANDA217205
Calcium Acetate	CALCIUM ACETATE	PD-Rx Pharmaceuticals, Inc.	925918d5-9f89-4f2f-9bb9-d9c53d90bb0a	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217205 application number: ANDA217205 ndc (package): 72789-422-97 ndc (product): 72789-422 ndc11 (package): 72789042297
Calcium Acetate	CALCIUM ACETATE	Nivagen Pharmaceuticals, Inc.	da6dc42d-1ae6-45ff-8a81-20a7135f8d17	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217205 application number: ANDA217205
Calcium Acetate	CALCIUM ACETATE	SQUARE PHARMACEUTICALS LIMITED	5af79d16-31ad-4d68-9a6d-bb5d9c91535d	2023-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217205 application number: ANDA217205

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	925918d5-9f89-4f2f-9bb9-d9c53d90bb0a	3
359296	calcium acetate 667 MG Oral Capsule	SCD	925918d5-9f89-4f2f-9bb9-d9c53d90bb0a	3
359296	calcium acetate 667 MG (calcium 169 MG) Oral Capsule	SY	925918d5-9f89-4f2f-9bb9-d9c53d90bb0a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72789-422-97	72789042297	200 CAPSULE in 1 BOTTLE, PLASTIC (72789-422-97)	200 capsule	2024-07-16	No	No	Current