Home NDC 53746-590 Calcium Acetate
Product NDC 53746-590
11-digit product format 537460590
Labeler code 53746
Product ID 53746-590_4daaf871-3ef0-4dea-b140-e67573ea5e9b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcium Acetate
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA201658
Marketing category ANDA
Marketing start 2014-10-08
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 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 RLD / RS 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# 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53746-590-01 Calcium Acetate 100 in 1 BOTTLE CAPSULE 100 4 53746-590-05 Calcium Acetate 500 in 1 BOTTLE CAPSULE 500 4 53746-590-20 Calcium Acetate 200 in 1 BOTTLE CAPSULE 200 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-590 CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 4 Current NDC, Legacy NDC, 3 package rows 20240101_4a490e1d-80ee-461f-aba6-01f54fe8a5fe.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53746-590-01 53746059001 100 CAPSULE in 1 BOTTLE (53746-590-01) 100 capsule 2014-10-08 0000-00-00 No No Current 53746-590-05 53746059005 500 CAPSULE in 1 BOTTLE (53746-590-05) 500 capsule 2014-10-08 0000-00-00 No No Current 53746-590-20 53746059020 200 CAPSULE in 1 BOTTLE (53746-590-20) 200 capsule 2014-10-08 0000-00-00 No No Current