NephPlex Rx

Product NDC
59528-0317
11-digit product format
595280317
Labeler code
59528
Product ID
59528-0317_f2dda9de-d72a-42c2-965f-b8cb8e69e19a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
multi vitamin/mineral supplement with ascorbic acid, niacin, pyridoxine, pantothenic acid, folic acid, riboflavin, thiamin, biotin, cobalamin and zinc.
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Nephro-Tech, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1995-07-01
Marketing end
0000-00-00
Substance
ASCORBIC ACID; NIACINAMIDE; ZINC OXIDE; PYRIDOXINE HYDROCHLORIDE; PANTOTHENIC ACID; RIBOFLAVIN; THIAMINE; FOLIC ACID; BIOTIN; COBALAMIN
Active strength
60 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Vitamin C [EPC],Ascorbic Acid [CS],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59528-0317IInactivated by FDA2026-10-05
excluded packagepackage59528-031759528-0317-1IInactivated by FDA2026-10-05

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59528-0317-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59528-0317-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59528-0317-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59528-0317-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59528-0317-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59528-0317-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59528-0317-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59528-0317-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59528-0317-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59528-0317-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59528-0317-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59528-0317-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59528-0317-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59528-0317-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59528-0317-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59528-0317-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59528-0317-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59528-0317-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59528-0317-12023-01-30C16284748780-19d75b9d0-1b5e-f424-e053-dadaa90a57ceNephPlex Rx
59528-0317-12021-07-13C16284748780-19d75b9d0-1b5e-f424-e053-dadaa90a57ceNephPlex Rx
59528-0317-12020-01-31C16284748780-19d75b9d0-1b5e-f424-e053-dadaa90a57ceNephPlex Rx

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59528-0317-1NephPlex Rx100 in 1 BOTTLE, PLASTICTABLET, COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59528-0317-1EA - Each59528-0317d46d2691-796d-4dc6-9bbe-0b8c8aec063712014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0RNEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
BIOTINACTIVE INGREDIENT6SO6U10H04NEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
COBALAMINACTIVE INGREDIENT8406EY2OQANEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
FOLIC ACIDACTIVE INGREDIENT935E97BOY8NEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
NIACINAMIDEACTIVE INGREDIENT25X51I8RD4NEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
PANTOTHENIC ACIDACTIVE INGREDIENT19F5HK2737NEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BVNEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
RIBOFLAVINACTIVE INGREDIENTTLM2976OFRNEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
THIAMINEACTIVE INGREDIENTX66NSO3N35NEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZNEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0RNEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
BIOTINACTIVE MOIETY6SO6U10H04NEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
COBALAMINACTIVE MOIETY8406EY2OQANEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
FOLIC ACIDACTIVE MOIETY935E97BOY8NEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
NIACINAMIDEACTIVE MOIETY25X51I8RD4NEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
PANTOTHENIC ACIDACTIVE MOIETY19F5HK2737NEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZNEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
RIBOFLAVINACTIVE MOIETYTLM2976OFRNEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
THIAMINE IONACTIVE MOIETY4ABT0J945JNEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37NEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59528-0317NEPHPLEX RX (MULTI VITAMIN/MINERAL SUPPLEMENT WITH ASCORBIC ACID, NIACIN, PYRIDOXINE, PANTOTHENIC ACID, FOLIC ACID, RIBOFLAVIN, THIAMIN, BIOTIN, COBALAMIN AND ZINC.) TABLET, COATED [NEPHRO-TECH, INC.]6Legacy NDC, 1 package rows20210714_ee2d5013-e0c3-4b35-a26e-d5d3897f13ca.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59528-0317-159528031701100 TABLET, COATED in 1 BOTTLE, PLASTIC (59528-0317-1) 1995-07-010000-00-00NoNoCurrent