Home NDC 62135-191-22 Calcium Acetate
Product NDC 62135-191
Requested package NDC 62135-191-22
11-digit product format 621350191
Labeler code 62135
Product ID 62135-191_06d3e4e6-38bb-e690-e063-6294a90af4d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcium Acetate
Dosage form CAPSULE
Route ORAL
Labeler Chartwell RX, LLC.
Application ANDA091312
Marketing category ANDA
Marketing start 2018-06-29
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 1 .
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 A091312-001 CALCIUM ACETATE CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091312-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091312-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2012-06-01 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 62135-191-22 Calcium Acetate 200 in 1 BOTTLE CAPSULE 200 5 62135-191-30 Calcium Acetate 30 in 1 BOTTLE CAPSULE 30 5 62135-191-73 Calcium Acetate 750 in 1 BOTTLE CAPSULE 750 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-191 CALCIUM ACETATE CAPSULE [CHARTWELL RX, LLC.] 5 Current NDC, Legacy NDC, 3 package rows 20231004_781c3f1f-b622-418b-8c0e-3407e9b90656.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 62135-191-22 62135019122 200 CAPSULE in 1 BOTTLE (62135-191-22) 200 capsule 2018-06-29 0000-00-00 No No Current