NDC 53489-601-01 - ZOLPIDEM TARTRATE

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: 53489-601
Requested NDC: 53489-601-01
Package NDCs from labels: 53489-601-07, 53489-601-06, 53489-601-01, 53489-601-03, 53489-601-05, 53489-601-10
Manufacturer: Mutual Pharmaceutical Company, Inc.
Effective date: 2007-05-04
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ZOLPIDEM TARTRATE - Mutual Pharmaceutical Company, Inc.	Mutual Pharmaceutical Company, Inc.	2007-05-04	HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53489-601-01	ZOLPIDEM TARTRATE	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	1
53489-601-03	ZOLPIDEM TARTRATE	250 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	250	1
53489-601-05	ZOLPIDEM TARTRATE	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	1
53489-601-06	ZOLPIDEM TARTRATE	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	1
53489-601-07	ZOLPIDEM TARTRATE	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	1
53489-601-10	ZOLPIDEM TARTRATE	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53489-601	ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1	6 package rows	20070524_A0E521C3-7807-464E-922D-CE8F23216828.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Zolpidem Tartrate	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1
Zolpidem	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1
Carnauba wax	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1
citric acid	INACTIVE INGREDIENT	2968PHW8QP	ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1
crospovidone	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1
hypromellose	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1
iron oxide red	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1
lactose monhydrate	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1
polydextrose	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1
polyethylene glycol	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1
povidone	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [MUTUAL PHARMACEUTICAL COMPANY, INC.]	1

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 4 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	78481108-4a1c-fce9-e053-2a91aa0a09ad	2024-06-12	Warnings, Adverse reactions	Exact identifier rxcui: 854876
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	70d7cfc3-7e54-4cd8-8911-7cf115d5c820	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854876
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	23bce69d-7918-42c2-8020-e22f292ff31f	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	3aa7e88b-7929-45ac-9e81-03f4abf28e94	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	1e5b61b6-a5bd-4f09-9d34-905ce32f1899	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aurobindo Pharma Limited	ea2067bd-1622-4d98-8012-2c09405aa88d	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854876 rxcui: 854873
Zolpidem Tartrate	ZOLPIDEM TARTRATE	NorthStar Rx LLC	51c9a29c-a285-40d0-bf3a-7e8c944ee39c	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854876 rxcui: 854873
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	df130798-1458-455b-a4e1-c33c4ecee43b	2023-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854876
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	33094305-4bbd-4b52-9079-8853d5f83682	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873
Zolpidem	ZOLPIDEM TARTRATE	ACI Healthcare USA, Inc	021153ce-fe27-4ed1-8d88-b4157b0ed734	2023-11-16	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854876 rxcui: 854873
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	A-S Medication Solutions	e68a1b3b-b3d1-495e-be46-466113e7dbd6	2023-09-14	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	67cc924a-26e0-431f-9160-32c9d92a46cd	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	8581cfad-525b-4b16-b116-a5138d9fda52	2022-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854876
Zolpidem	ZOLPIDEM TARTRATE	Proficient Rx LP	f76eb9d8-ca7d-4479-bd16-52a57f623b02	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Proficient Rx LP	eaca34da-2b12-4dd4-91b5-a8446c7bd41e	2022-07-01	Warnings, Adverse reactions	Exact identifier rxcui: 854873
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Proficient Rx LP	e1f43bde-efba-42be-adef-94e1ef6664fd	2022-04-01	Warnings, Adverse reactions	Exact identifier rxcui: 854876
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	e534b3ac-1110-465f-8692-6ea585996fb6	2019-11-01	Warnings, Adverse reactions	Exact identifier rxcui: 854873
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	e8572fd4-70c7-4c94-a0d7-9b4be6fa8f77	2019-11-01	Warnings, Adverse reactions	Exact identifier rxcui: 854876
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	acfcfe91-83a0-44ab-95c0-dd98b73ac69a	2019-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	7be7f243-e6f8-406f-aed7-be7cedd5630a	2018-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854876

Reported adverse events (FAERS/openFDA)#

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