NDC 43598-582-01 - Buprenorphine and Naloxone

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: 43598-582
Requested NDC: 43598-582-01
Package NDCs from labels: 43598-582-01, 43598-582-30
Manufacturer: Dr.Reddys Laboratories Inc | LTS Lohmann Therapy Systems Corp. | Pharmaron Manufacturing services (UK) LTD
Effective date: 2026-01-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Buprenorphine and Naloxone	Dr.Reddys Laboratories Inc \| LTS Lohmann Therapy Systems Corp. \| Pharmaron Manufacturing services (UK) LTD	2026-01-12	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43598-582-01	Buprenorphine and Naloxone	1 in 1 POUCH	FILM, SOLUBLE	1		10
43598-582-30	Buprenorphine and Naloxone	30 in 1 CARTON	FILM, SOLUBLE	30		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-582	BUPRENORPHINE AND NALOXONE FILM, SOLUBLE [DR.REDDYS LABORATORIES INC]	8	Current NDC, Legacy NDC, 2 package rows	20240125_718756d7-0131-b173-6c45-5ee039b311b0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-582-01	EA - Each	43598-582	ac240495-394d-4d2c-a4af-3a460fd441fa	1	2018-07-03
43598-582-30	EA - Each	43598-582	d112c6a1-d08e-493d-bb99-32ab384e5395	1	2018-07-03

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 13 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	448a1dc5-7a98-4b2f-82af-4b92de05cfc3	2019-11-18		Exact identifier unii: XF417D3PSL
Ammonia Inhalants	AMMONIA INHALANTS	James Alexander Corporation	b741afa6-e56c-4fbb-ada0-80b80aef72a7	2019-01-31	Warnings	Exact identifier unii: 5138Q19F1X
First Aid Only Ammonia Inhalants	AMMONIA INHALANTS	Acme United Corporation	6595a2a5-f2d7-85cf-e053-2991aa0a9b52	2018-02-19	Warnings	Exact identifier unii: 5138Q19F1X
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	051f7347-5a76-4664-8fe2-e61b3dfcb0e4	2014-08-27		Exact identifier unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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