Home NDC 75834-323 Calcium Acetate
Product NDC 75834-323
11-digit product format 758340323
Labeler code 75834
Product ID 75834-323_da6dc42d-1ae6-45ff-8a81-20a7135f8d17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcium Acetate
Dosage form CAPSULE
Route ORAL
Labeler Nivagen 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 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 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 RLD / RS Approval date Source SHA-256 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# 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 75834-323-02 Calcium Acetate 200 in 1 BOTTLE CAPSULE 200 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75834-323 CALCIUM ACETATE CAPSULE [NIVAGEN PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20231207_da6dc42d-1ae6-45ff-8a81-20a7135f8d17.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 75834-323-02 75834032302 200 CAPSULE in 1 BOTTLE (75834-323-02) 200 capsule 2023-12-07 No No Current