Home NDC 68382-642 CALCIUM ACETATE
Product NDC 68382-642
11-digit product format 683820642
Labeler code 68382
Product ID 68382-642_71154665-be56-47ef-8f1f-5997a6f86b2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CALCIUM ACETATE
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA202885
Marketing category ANDA
Marketing start 2012-02-23
Marketing end 0000-00-00
Substance CALCIUM ACETATE
Active strength 667 mg/1
Pharmacologic classes Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A202885-001 CALCIUM ACETATE CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202885-001 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.
Product history page 1 of 2 · 44 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 2026-10-15 13:18:30 2026-09 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202885-001 CALCIUM ACETATE 667MG TABLET / ORAL AB 2015-01-22 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A202885-001 AB 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202885-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202885-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202885-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68382-642-10 CALCIUM ACETATE 1000 in 1 BOTTLE TABLET 1000 4 68382-642-66 CALCIUM ACETATE 200 in 1 BOTTLE TABLET 200 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-642 CALCIUM ACETATE TABLET [ZYDUS PHARMACEUTICALS USA INC.] 4 Legacy NDC, 2 package rows 20150204_f86caa76-047c-4be7-8c11-cba6c00a44ed.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CALCIUM ACETATE CALCIUM ACETATE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ac4975aa-0ee9-4473-81e2-839f1556e684 2023-07-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 202885 application number: ANDA202885
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68382-642-10 68382064210 1000 in 1 BOTTLE Historical 68382-642-66 68382064266 200 in 1 BOTTLE Historical