NDC 85592-829-01 - LACTULOSE Crystalline

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: 85592-829
Requested NDC: 85592-829-01
Package NDCs from labels: 85592-829-01, 85592-829-30
Manufacturer: Cumberland Assured Products Inc.
Effective date: 2025-09-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
LACTULOSE For Oral Solution	Cumberland Assured Products Inc.	2025-09-01	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85592-829-01	LACTULOSE Crystalline	20 g in 1 POUCH	POWDER, FOR SOLUTION	20		2
85592-829-30	LACTULOSE Crystalline	30 in 1 CARTON	POWDER, FOR SOLUTION	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
85592-829-01	EA - Each	85592-829	558a389e-2eb6-438f-8bdf-52f40398a7ce	1	2025-12-16
85592-829-30	EA - Each	85592-829	addb74f5-b767-4011-8f64-9e827def0716	1	2025-12-16

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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Generlac	LACTULOSE	Chartwell RX, LLC	35207edd-a5fe-4369-a079-7a8b0d2f2e91	2024-07-16	Warnings, Adverse reactions	Exact identifier unii: 9U7D5QH5AE
LACTULOSE	LACTULOSE	Proficient Rx LP	6bbabdc6-f6a8-4f67-a448-e452d1928deb	2024-06-01	Warnings, Adverse reactions	Exact identifier unii: 9U7D5QH5AE
Lactulose Solution	LACTULOSE SOLUTION USP, 10 G/15 ML	Bajaj Medical, LLC	d460b1a2-9091-2ac9-e053-2995a90aa1d2	2022-12-26	Warnings, Adverse reactions	Exact identifier unii: 9U7D5QH5AE
Lactulose	LACTULOSE	Fresenius Kabi Austria GmbH	a89835c9-8ce5-4627-8d7d-70ff175b2e07	2022-11-09	Adverse reactions	Exact identifier unii: 9U7D5QH5AE
Constulose	LACTULOSE	Actavis Pharma, Inc.	461ec39f-eeb4-4460-9b5c-62367d47162b	2022-06-01	Warnings, Adverse reactions	Exact identifier unii: 9U7D5QH5AE
Enulose	LACTULOSE	Actavis Pharma, Inc.	00c42c5c-d19e-4130-aa08-a8bbd47d3e5b	2022-06-01	Warnings, Adverse reactions	Exact identifier unii: 9U7D5QH5AE
LACTULOSE	LACTULOSE	Lannett Company, Inc.	6619b25c-26b7-4c43-8c4f-9d33a23c61ca	2020-01-30	Warnings, Adverse reactions	Exact identifier unii: 9U7D5QH5AE
KRISTALOSE	LACTULOSE	Cumberland Pharmaceuticals Inc.	535dd1ea-b567-49f7-9a84-8ea91e78c466	2018-09-17	Warnings, Adverse reactions	Exact identifier application number: ANDA074712 rxcui: 1251194 rxcui: 1251190 unii: 9U7D5QH5AE

Reported adverse events (FAERS/openFDA)#

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