Home NDC 0178-0797 Citranatal Harmony 2.1
Product NDC 0178-0797
11-digit product format 001780797
Labeler code 0178
Product ID 0178-0797_88dc0784-2854-b47f-e053-2a95a90ac51a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Mission Pharmacal Company
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2013-01-21
Marketing end 0000-00-00
Substance CALCIUM CITRATE; IRON
Active strength 104 mg/1; mg/1
Pharmacologic classes Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 43 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0178-0797-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0178-0797-30 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0178-0797-05 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0178-0797-30 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0178-0797-05 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0178-0797-30 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0178-0797-05 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0178-0797-30 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0178-0797-05 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0178-0797-30 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0178-0797-05 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0178-0797-30 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0178-0797-05 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0178-0797-30 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0178-0797-05 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0178-0797-30 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0178-0797-05 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0178-0797-30 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0178-0797-05 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0178-0797-30 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0178-0797-05 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0178-0797-30 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0178-0797-05 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0178-0797-30 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 0178-0797-05 2021-01-29 C162847 48780-1 ba0f9c33-44b2-a910-e053-dadaa90a0b85 These highlights do not include all the information needed to use CitraNatal Harmony ® safely and effectively. See full prescribing information for CitraNatal Harmony ® . CitraNatal Harmony ® (Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent) capsules for oral use. Initial U.S. Approval: 2012 0178-0797-30 2021-01-29 C162847 48780-1 ba0f9c33-44b2-a910-e053-dadaa90a0b85 These highlights do not include all the information needed to use CitraNatal Harmony ® safely and effectively. See full prescribing information for CitraNatal Harmony ® . CitraNatal Harmony ® (Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent) capsules for oral use. Initial U.S. Approval: 2012
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0178-0797-05 Citranatal Harmony 2.1 5 in 1 BOTTLE CAPSULE, GELATIN COATED 5 3 0178-0797-05 Citranatal Harmony 2.1 1 in 1 CARTON CAPSULE, GELATIN COATED 1 3 0178-0797-30 Citranatal Harmony 2.1 30 in 1 BOTTLE CAPSULE, GELATIN COATED 30 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALCIUM CITRATE ACTIVE INGREDIENT MLM29U2X85 CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY] 1 IRON ACTIVE INGREDIENT E1UOL152H7 CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY] 1 CALCIUM CATION ACTIVE MOIETY 2M83C4R6ZB CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY] 1 IRON ACTIVE MOIETY E1UOL152H7 CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY] 1 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY] 1 CHOLECALCIFEROL INACTIVE INGREDIENT 1C6V77QF41 CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY] 1 DOCONEXENT INACTIVE INGREDIENT ZAD9OKH9JC CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY] 1 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY] 1 FOLIC ACID INACTIVE INGREDIENT 935E97BOY8 CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY] 1 PYRIDOXINE INACTIVE INGREDIENT KV2JZ1BI6Z CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0178-0797 CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY] 3 Legacy NDC, 3 package rows 20190515_00ecf076-d840-bee7-38d1-48bae1066bff.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 0178-0797-05 00178079705 5 in 1 BOTTLE Historical 0178-0797-30 00178079730 30 in 1 BOTTLE Historical