Home NDC 76282-377 Calcium Acetate
Product NDC 76282-377
11-digit product format 762820377
Labeler code 76282
Product ID 76282-377_b22d0aaf-0636-492b-981f-6c220640c1cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcium Acetate
Dosage form CAPSULE
Route ORAL
Labeler EXELAN PHARMACEUTICALS, INC.
Application ANDA203135
Marketing category ANDA
Marketing start 2014-04-14
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 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 A203135-001 CALCIUM ACETATE CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203135-001 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 · 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 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB RS 2013-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203135-001 CALCIUM ACETATE 667MG CAPSULE / ORAL AB 2013-02-07 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 76282-377-02 Calcium Acetate 200 in 1 BOTTLE CAPSULE 200 6 76282-377-60 Calcium Acetate 60 in 1 BOTTLE CAPSULE 60 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALCIUM ACETATE ACTIVE INGREDIENT Y882YXF34X CALCIUM ACETATE CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 CALCIUM CATION ACTIVE MOIETY 2M83C4R6ZB CALCIUM ACETATE CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CALCIUM ACETATE CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY CALCIUM ACETATE CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CALCIUM ACETATE CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L CALCIUM ACETATE CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CALCIUM ACETATE CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI CALCIUM ACETATE CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CALCIUM ACETATE CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76282-377 CALCIUM ACETATE CAPSULE [EXELAN PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20230316_a5725f95-621e-425b-946d-434b3fec24eb.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 · 3 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 76282-377-02 76282037702 200 CAPSULE in 1 BOTTLE (76282-377-02) 200 capsule 2014-04-14 0000-00-00 No No Current 76282-377-60 76282037760 60 CAPSULE in 1 BOTTLE (76282-377-60) 60 capsule 2014-04-14 0000-00-00 No No Current