Lactulose Solution

Manufacturer: TriRx Huntsville Pharmaceutical Services, LLC
Effective date: 2023-01-10
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 21:41:09

Label at a glance#

ProductLactulose Solution

Active ingredientLACTULOSE

Label structure11 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Label Description

CLINICAL PHARMACOLOGY SECTION

label Clinical Pharmacology

These highlights do not include all the information needed to use. See full prescribing information for Lactulose Initial U.S. approval

INDICATIONS & USAGE SECTION

label indications and usage

These Highlights do not include all the information needed to use. See full prescribing information for Lactulose Intial U.S. Approval

CONTRAINDICATIONS SECTION

Label Contraindications

WARNINGS SECTION

label warnings

PRECAUTIONS SECTION

label precautions

These highlights do not include all the information needed to use. See full prescribing information for Lactulose Initial U.S. Approval. To report suspected adverse reactions contact lannet Company Inc at 1-800-332-1088

ADVERSE REACTIONS SECTION

Label Adverse Reactions

OVERDOSAGE SECTION

label-overdoseLabel Overdose cont

These highlights do not include all the information needed to use. See full prescribing information for Lactulose Initial U.S. Approval

DOSAGE & ADMINISTRATION SECTION

Label-Dosage and Administration

HOW SUPPLIED SECTION

label How Supplied

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Display image

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Lactulose Solution
FD&C YELLOW NO. 6
FD&C BLUE NO. 1
WATER
LACTULOSE
SODIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80432-001	80432-001-33

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C YELLOW NO. 6	H77VEI93A8	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
WATER	059QF0KO0R	IACT
LACTULOSE	9U7D5QH5AE	ACTIB
SODIUM HYDROXIDE	55X04QC32I	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075993-001	LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		2001-07-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A075993-001	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075993-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075993-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075993-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075993-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075993-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075993-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075993-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075993-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075993-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075993-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075993-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075993-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075993-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075993-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075993-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075993-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075993-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075993-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075993-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075993-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075993-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075993-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075993-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075993-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075993-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075993-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075993-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075993-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075993-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075993-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075993-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075993-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075993-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075993-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075993-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075993-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075993-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075993-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075993-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075993-001	AA	1	`f41ea6bd6efb…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f1f0ab04-0096-9db4-e053-2995a90aa04c			b8434772-26c8-fce9-e053-2995a90abc7c	2023-01-10	Warnings, Adverse reactions	Exact identifier spl id: f1f0ab04-0096-9db4-e053-2995a90aa04c spl set id: b8434772-26c8-fce9-e053-2995a90abc7c

Reported adverse events (FAERS/openFDA)#

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