Constulose

Product NDC: 50090-3436
11-digit product format: 500903436
Labeler code: 50090
Product ID: 50090-3436_a0bed20c-bdb6-42a7-84ec-676852a0a352
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lactulose
Dosage form: SOLUTION
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA090503
Marketing category: ANDA
Marketing start: 2011-02-28
Marketing end: 0000-00-00
Substance: LACTULOSE
Active strength: 10 g/15mL
Pharmacologic classes: Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-3436		I	Inactivated by FDA		2026-08-10
excluded package	package	50090-3436	50090-3436-0	I	Inactivated by FDA		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-3436-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3436-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-3436-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-3436-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-3436-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-3436-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-3436-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-3436-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-3436-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-3436-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-3436-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-3436-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-3436-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-3436-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-3436-0	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A090503-001	LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		2012-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090503-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090503-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2012-01-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090503-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090503-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090503-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090503-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090503-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090503-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090503-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090503-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090503-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090503-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090503-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090503-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090503-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090503-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090503-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090503-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090503-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090503-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090503-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090503-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090503-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090503-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090503-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090503-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090503-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090503-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090503-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090503-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090503-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090503-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090503-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090503-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090503-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090503-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090503-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090503-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090503-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090503-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090503-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090503-001	AA	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3436-0	2023-01-30	C162847	48780-1	f386c64a-0b10-0266-e053-dadaa90a7c1a	(Lactulose Solution USP, 10 g/15 mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3436-0	Constulose	237 mL in 1 BOTTLE	SOLUTION	237		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3436-0	ML - Milliliter	50090-3436	96becf80-530e-46e3-aaf0-1f4db0ee8e30	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3436	CONSTULOSE (LACTULOSE) SOLUTION [A-S MEDICATION SOLUTIONS]	4	Legacy NDC, 1 package rows	20210303_f34607bc-d4d3-4997-b4fb-1950efbc15ba.zip

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
Constulose	LACTULOSE	Actavis Pharma, Inc.	461ec39f-eeb4-4460-9b5c-62367d47162b	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090503 application number: ANDA090503

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
544452	Constulose 10 GM in 15 mL Oral Solution	PSN	f34607bc-d4d3-4997-b4fb-1950efbc15ba	4
391937	lactulose 10 GM in 15 mL Oral Solution	PSN	f34607bc-d4d3-4997-b4fb-1950efbc15ba	4
544452	lactulose 667 MG/ML Oral Solution [Constulose]	SBD	f34607bc-d4d3-4997-b4fb-1950efbc15ba	4
391937	lactulose 667 MG/ML Oral Solution	SCD	f34607bc-d4d3-4997-b4fb-1950efbc15ba	4
544452	Constulose 10 GM per 15 ML Syrup	SY	f34607bc-d4d3-4997-b4fb-1950efbc15ba	4
544452	Constulose 667 MG/ML Oral Solution	SY	f34607bc-d4d3-4997-b4fb-1950efbc15ba	4
391937	lactulose 10 GM per 15 ML Oral Solution	SY	f34607bc-d4d3-4997-b4fb-1950efbc15ba	4
391937	lactulose 20 GM per 30 ML Oral Solution	SY	f34607bc-d4d3-4997-b4fb-1950efbc15ba	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3436-0	50090343600	237 mL in 1 BOTTLE (50090-3436-0)	237 ml	2018-04-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
(Lactulose Solution USP, 10 g/15 mL)	A-S Medication Solutions	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	4