Calcium Acetate
- Product NDC
- 68084-479
- Requested package NDC
- 68084-479-01
- 11-digit product format
- 680840479
- Labeler code
- 68084
- Product ID
- 68084-479_47e53e0e-be75-f24b-e063-6394a90a833f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcium Acetate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA077728
- Marketing category
- ANDA
- Marketing start
- 2013-07-18
- 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
Orange Book products#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 84e616aacf4f… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077728-001 | AB | 1 | 84e616aacf4f… |
| 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… |
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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CALCIUM ACETATE | 667 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| Y882YXF34X | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 359296 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1090762c-eec1-4ab0-9ddc-43caa764cd0e | Available on FDA.report |
DailyMed Product Concepts#
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68084-479-01 | Calcium Acetate | 100 in 1 CARTON | CAPSULE | 100 | 8 | |
| 68084-479-11 | Calcium Acetate | 1 in 1 BLISTER PACK | CAPSULE | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68084-479-01 | EA - Each | 68084-479 | 77771547-ebea-4b14-9e2b-9822a455f933 | 1 | 2013-09-04 |
| 68084-479-11 | EA - Each | 68084-479 | d0f3d525-a1b7-46af-b206-fd34f5584940 | 1 | 2013-09-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| 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 | 077728 ANDA077728 |
| Calcium Acetate | CALCIUM ACETATE | Major Pharmaceuticals | 9a731cdf-6488-44ca-b97f-512a0e9deab1 | 2026-03-17 | Warnings, Adverse reactions | 077728 ANDA077728 |
| Calcium Acetate | CALCIUM ACETATE | American Health Packaging | 1090762c-eec1-4ab0-9ddc-43caa764cd0e | 2026-01-08 | Warnings, Adverse reactions | 077728 ANDA077728 68084-479-01 68084-479 68084047901 |
| Calcium Acetate | CALCIUM ACETATE | Hikma Pharmaceuticals USA Inc. | 85fd41f8-2823-44ca-a15e-f1f2e5d0ff94 | 2025-04-17 | Warnings, Adverse reactions | 077728 ANDA077728 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 359296 | calcium acetate 667 MG (Ca 169 MG) Oral Capsule | PSN | 1090762c-eec1-4ab0-9ddc-43caa764cd0e | 8 |
| 359296 | calcium acetate 667 MG Oral Capsule | SCD | 1090762c-eec1-4ab0-9ddc-43caa764cd0e | 8 |
| 359296 | calcium acetate 667 MG (calcium 169 MG) Oral Capsule | SY | 1090762c-eec1-4ab0-9ddc-43caa764cd0e | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68084-479-01 | 68084047901 | 100 BLISTER PACK in 1 CARTON (68084-479-01) / 1 CAPSULE in 1 BLISTER PACK (68084-479-11) | 100 blister pack | 2013-07-18 | 0000-00-00 | No | No | Current |