Active ingredient
Calcium Acetate
30 finished FDA listings contain Calcium Acetate as their only active ingredient; 7 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CALCIUM ACETATE, CALCIUM ACETATE MONOHYDRATE
- Dosage forms
- Capsule, Pellet, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 21
- Strengths listed
- 1 [hp_m]/1 · 1 [hp_q]/1 · 100 [hp_c]/1 · 12 [hp_c]/1 · 200 [hp_c]/1 · 30 [hp_c]/1 · 500 [hp_c]/1 · 6 [hp_c]/1 · 667 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 214342
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 077728 | HIKMA | 2008-02-26 | 4 |
| ANDA 091312 | CHARTWELL RX | 2012-06-01 | 1 |
| ANDA 202420 | CHARTWELL MOLECULAR | 2013-02-05 | 1 |
| ANDA 203135 | INVAGEN PHARMS | 2013-02-07 | 3 |
| ANDA 201658 | AMNEAL PHARMS | 2014-10-06 | 1 |
| ANDA 202885 | HERITAGE PHARMS INC | 2015-01-22 | 1 |
| ANDA 202315 | HERITAGE PHARMS INC | 2015-06-29 | 3 |
| ANDA 203179 | MPP PHARMA | 2015-10-26 | 3 |
| ANDA 211038 | COHANCE LIFESCIENCES | 2020-02-21 | 1 |
| ANDA 217205 | ADAPTIS | 2023-03-13 | 4 |
Official labeling on DailyMed
- CALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING] · version 2 · 2026-09-10
- CALCIUM ACETATE CAPSULE [REMEDYREPACK INC.] · version 4 · 2026-09-07
- CALCIUM ACETATE CAPSULE [AVPAK] · version 1 · 2026-05-29
- CALCIUM ACETATE CAPSULE [RISING PHARMA HOLDINGS, INC.] · version 6 · 2026-05-20
- CALCIUM ACETATE CAPSULE [CARDINAL HEALTH 107, LLC] · version 5 · 2026-04-23
- CALCIUM ACETATE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] · version 2 · 2026-04-22
- CALCIUM ACETATE CAPSULE [MAJOR PHARMACEUTICALS] · version 5 · 2026-03-26
- CALCIUM ACETATE CAPSULE [WESTMINSTER PHARMACEUTICALS, LLC] · version 3 · 2026-02-26
- CALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING] · version 8 · 2026-01-14
- CALCIUM ACETATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 3 · 2025-11-17
- CALCIUM ACETATE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 12 · 2025-07-07
- CALCIUM ACETATE CAPSULE [PROFICIENT RX LP] · version 1 · 2025-06-30
Showing the 12 most recent of 23 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.