Home NDC 65162-590 Calcium Acetate
Product NDC 65162-590
11-digit product format 651620590
Labeler code 65162
Product ID 65162-590_726db9f7-007a-466c-ba47-41149ee217be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcium Acetate
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA201658
Marketing category ANDA
Marketing start 2014-10-08
Marketing end 0000-00-00
Substance CALCIUM ACETATE
Active strength 667 mg/1
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 65162-590-20 excluded package package 65162-590-50 excluded package package 65162-590-10
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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALCIUM ACETATE ACTIVE INGREDIENT Y882YXF34X CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 CALCIUM CATION ACTIVE MOIETY 2M83C4R6ZB CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 GELATIN INACTIVE INGREDIENT 2G86QN327L CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 SHELLAC INACTIVE INGREDIENT 46N107B71O CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 CALCIUM ACETATE ACTIVE INGREDIENT Y882YXF34X CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 CALCIUM ACETATE ACTIVE INGREDIENT Y882YXF34X CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 CALCIUM CATION ACTIVE MOIETY 2M83C4R6ZB CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 CALCIUM CATION ACTIVE MOIETY 2M83C4R6ZB CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVKARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-590 CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS LLC] 15 Legacy NDC 20241025_5bbed4df-5883-49fc-adae-1af4073bb860.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65162-590-10 65162059010 100 CAPSULE in 1 BOTTLE (65162-590-10) 100 capsule 2014-10-08 0000-00-00 No No Current 65162-590-20 65162059020 200 CAPSULE in 1 BOTTLE (65162-590-20) 200 capsule 2014-10-08 0000-00-00 No No Current 65162-590-50 65162059050 500 CAPSULE in 1 BOTTLE (65162-590-50) 500 capsule 2014-10-08 0000-00-00 No No Current