NDC 16729-458-17 - Levothyroxine sodium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 16729-458
Requested NDC: 16729-458-17
Package NDCs from labels: 16729-458-15, 16729-458-17
Manufacturer: ASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date: 2026-02-06
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Levothyroxine sodium - ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-02-06	HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine sodium - Accord Healthcare Inc. \| Excella GmbH & Co. KG \| Intas Pharmaceuticals Limited	Accord Healthcare Inc. \| Excella GmbH & Co. KG \| Intas Pharmaceuticals Limited	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16729-458-15	Levothyroxine sodium	90 in 1 BOTTLE	TABLET	90		11
16729-458-17	Levothyroxine sodium	1000 in 1 BOTTLE	TABLET	1000		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-458	LEVOTHYROXINE SODIUM TABLET [ACCORD HEALTHCARE INC.]	10	Current NDC, Legacy NDC, 2 package rows	20241108_a6233381-3043-4e9a-aaa6-a6b105e5142b.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 18 · 353 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	bc9385d0-5c67-4bde-94da-e621347e2cba	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA212399 rxcui: 966270 unii: 9J765S329G
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	4c903249-69e9-4168-a9d1-22e6c2c1eb22	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA212399 rxcui: 966220 unii: 9J765S329G
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	6f25cbb3-0358-4778-b8f0-f76479a2dcc5	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA212399 rxcui: 892246 unii: 9J765S329G
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	7fd988be-ab3d-406d-a55d-1e5a8a2101cc	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA212399 rxcui: 966224 unii: 9J765S329G
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	6108759a-783e-42ca-b078-6a3cd84ce901	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA212399 rxcui: 966225 unii: 9J765S329G
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	13e03769-9a4f-497f-9afa-95bf525090b3	2026-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 966221 unii: 9J765S329G
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	NorthStar RxLLC	58f4dc90-3648-49dc-a7e1-baf918a773b5	2026-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 966248 rxcui: 892251 rxcui: 966222 rxcui: 966270 rxcui: 892246 rxcui: 966221 rxcui: 966224 rxcui: 966249 rxcui: 966220 rxcui: 966225 rxcui: 966253 unii: 9J765S329G
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	597ea445-d926-adc6-e063-6394a90a6446	2026-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 966222 unii: 9J765S329G
PNV Prenatol	MULTIVITAMIN	PureTek Corporation	583f0194-0306-f31b-e063-6394a90a2a10	2026-08-06	Warnings, Adverse reactions	Exact identifier unii: 3A3U0GI71G
PRENATE Restore	ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENT	Avion Pharmaceuticals, LLC	1076ba9a-0168-492f-ba9b-99fa02186092	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 3A3U0GI71G
PNV-Omega	ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENT	Acella Pharmaceuticals, LLC	735c5531-137f-4cee-8c68-ae121045a8ff	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 3A3U0GI71G
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	55f4c679-86cb-b97f-e063-6294a90ad5ef	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 966221 unii: 9J765S329G
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	55f67831-4680-edbf-e063-6294a90a1d36	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 966270 unii: 9J765S329G
Magnesium Oxide	MAGNESIUM OXIDE	Westminster Pharmaceuticals, LLC	52eeac0e-94bb-48c3-81dc-578e96406c01	2026-07-06	Warnings	Exact identifier unii: 3A3U0GI71G
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	489ffba8-983e-478f-8f62-fe08bf3d0e0b	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 966224 unii: 9J765S329G
Vitramyn	FOLIC ACID	PureTek Corporation	c8af7616-5178-6df0-e053-2a95a90a334d	2026-06-18	Warnings, Adverse reactions	Exact identifier unii: 3A3U0GI71G
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	544d67eb-8487-cb5d-e063-6394a90a3110	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 892251 unii: 9J765S329G
Prenate Mini	ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS ASPARTO GLYCINATE, IRON, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND LOWBUSH BLUEBERRY	Avion Pharmaceuticals, LLC	8ab766c2-d554-4141-92b2-fbe038e80c9f	2026-06-12	Boxed warning, Adverse reactions	Exact identifier unii: 3A3U0GI71G
Prenate Essential	ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND ICOSAPENT	Avion Pharmaceuticals, LLC	e5acfb2a-0959-4542-9b4c-790be194d581	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 3A3U0GI71G
Prenate Elite	.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, CYANOCOBALAMIN, BIOTIN, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDE	Avion Pharmaceuticals, LLC	9b79c950-4312-4a53-9e36-fb8e00b053df	2026-06-12	Boxed warning, Adverse reactions	Exact identifier unii: 3A3U0GI71G

Reported adverse events (FAERS/openFDA)#

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