Lactulose

Product NDC: 73352-905
11-digit product format: 733520905
Labeler code: 73352
Product ID: 73352-905_3eaf2342-fb58-e0a5-e063-6394a90a7271
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lactulose
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Trifluent Pharma, Inc.
Application: ANDA217914
Marketing category: ANDA
Marketing start: 2025-09-13
Substance: LACTULOSE
Active strength: 20 g/20g
Pharmacologic classes: Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217914-001	LACTULOSE	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL	AA		2025-03-14
A217914-002	LACTULOSE	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL	AA		2025-03-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A217914-001	AA
A217914-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217914-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL	AA	2025-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217914-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL	AA	2025-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217914-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL	AA	2025-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217914-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL	AA	2025-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217914-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL	AA	2025-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217914-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL	AA	2025-03-14	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217914-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL	AA	2025-03-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217914-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL	AA	2025-03-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217914-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217914-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217914-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217914-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217914-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217914-002	AA	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217914-001	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217914-002	AA	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217914-001	CGT	2025-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217914-002	CGT	2025-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217914-001	CGT	2025-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217914-002	CGT	2025-09-13	`6a471c1ec25d…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lactulose
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LACTULOSE	20 g/20g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9U7D5QH5AE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1251190	Internal RxNorm lookup
1251194	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3eaf273a-b49d-2595-e063-6394a90a1cf6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
13620a32-e3b4-4aad-8280-283dce30ddff	Product name	1	20260105
27883b46-af31-44b0-b4ce-e6b4f6d825a7	Product name	4	20250812
c1a80c95-0e51-52a0-75fa-75808f51ded8	Product name	2	20150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73352-905-01	Lactulose	20 g in 1 POUCH	POWDER, FOR SOLUTION	20		1
73352-905-15	Lactulose	15 in 1 CARTON	POWDER, FOR SOLUTION	15		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73352-905-01	EA - Each	73352-905	b871561d-5d97-4bc3-909a-c9a3e13dfcba	1	2025-10-14
73352-905-15	EA - Each	73352-905	34b0a630-1a4f-4882-b34f-da8ca4bcad75	1	2025-10-14

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lactulose	LACTULOSE	PAI Holdings, LLC dba PAI Pharma	5ae4b6da-44df-419a-9f2b-8c4d79f635c8	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217914 application number: ANDA217914
Lactulose	LACTULOSE	Trifluent Pharma, Inc.	3eaf273a-b49d-2595-e063-6394a90a1cf6	2025-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217914 application number: ANDA217914 ndc (product): 73352-905

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9U7D5QH5AE	LACTULOSE	4618-18-2	LACTULOSE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1251190	lactulose 10 GM Powder for Oral Solution	PSN	3eaf273a-b49d-2595-e063-6394a90a1cf6	1
1251194	lactulose 20 GM Powder for Oral Solution	PSN	3eaf273a-b49d-2595-e063-6394a90a1cf6	1
1251190	lactulose 10000 MG Powder for Oral Solution	SCD	3eaf273a-b49d-2595-e063-6394a90a1cf6	1
1251194	lactulose 20000 MG Powder for Oral Solution	SCD	3eaf273a-b49d-2595-e063-6394a90a1cf6	1
1251190	lactulose 10 GM Granules for Oral Solution	SY	3eaf273a-b49d-2595-e063-6394a90a1cf6	1
1251190	lactulose 10 GM Powder for Oral Solution	SY	3eaf273a-b49d-2595-e063-6394a90a1cf6	1
1251194	lactulose 20 GM Granules for Oral Solution	SY	3eaf273a-b49d-2595-e063-6394a90a1cf6	1
1251194	lactulose 20 GM Powder for Oral Solution	SY	3eaf273a-b49d-2595-e063-6394a90a1cf6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73352-905-01	73352090501	20 g in 1 POUCH	20 g				Historical
73352-905-15	73352090515	15 POUCH in 1 CARTON (73352-905-15) / 20 g in 1 POUCH (73352-905-01)	15 pouch	2025-09-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LACTULOSE FOR ORAL SOLUTION Rx only	Trifluent Pharma, Inc.	2025-09-13	HUMAN PRESCRIPTION DRUG LABEL	1