Constulose

Product NDC: 45963-439
11-digit product format: 459630439
Labeler code: 45963
Product ID: 45963-439_7fd63ff0-fccd-408a-9c56-2c2fefdb74fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lactulose
Dosage form: SOLUTION
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA090503
Marketing category: ANDA
Marketing start: 2011-02-28
Substance: LACTULOSE
Active strength: 10 g/15mL
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 · 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LACTULOSE	10 g/15mL

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
391937	Internal RxNorm lookup
544452	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
461ec39f-eeb4-4460-9b5c-62367d47162b	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
45963-439-63	Constulose	237 mL in 1 BOTTLE	SOLUTION	237		6
45963-439-65	Constulose	946 mL in 1 BOTTLE	SOLUTION	946		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45963-439-63	ML - Milliliter	45963-439	80569c45-a54f-4fd4-905a-b7fe7c589bec	1	2012-07-24
45963-439-65	ML - Milliliter	45963-439	9bccae62-a628-4fe5-b5f0-e554c61aaa0d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
LACTULOSE	ACTIVE INGREDIENT	9U7D5QH5AE	CONSTULOSE (LACTULOSE) SOLUTION [ACTAVIS INC.]	2
LACTULOSE	ACTIVE MOIETY	9U7D5QH5AE	CONSTULOSE (LACTULOSE) SOLUTION [ACTAVIS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45963-439	CONSTULOSE (LACTULOSE) SOLUTION [ACTAVIS PHARMA, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20221013_461ec39f-eeb4-4460-9b5c-62367d47162b.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 ndc (product): 45963-439

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	461ec39f-eeb4-4460-9b5c-62367d47162b	6
391937	lactulose 10 GM in 15 mL Oral Solution	PSN	461ec39f-eeb4-4460-9b5c-62367d47162b	6
544452	lactulose 667 MG/ML Oral Solution [Constulose]	SBD	461ec39f-eeb4-4460-9b5c-62367d47162b	6
391937	lactulose 667 MG/ML Oral Solution	SCD	461ec39f-eeb4-4460-9b5c-62367d47162b	6
544452	Constulose 10 GM per 15 ML Syrup	SY	461ec39f-eeb4-4460-9b5c-62367d47162b	6
544452	Constulose 667 MG/ML Oral Solution	SY	461ec39f-eeb4-4460-9b5c-62367d47162b	6
391937	lactulose 10 GM per 15 ML Oral Solution	SY	461ec39f-eeb4-4460-9b5c-62367d47162b	6
391937	lactulose 20 GM per 30 ML Oral Solution	SY	461ec39f-eeb4-4460-9b5c-62367d47162b	6
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
45963-439-63	45963043963	237 mL in 1 BOTTLE (45963-439-63)	237 ml	2011-02-28	0000-00-00	No	No	Current
45963-439-65	45963043965	946 mL in 1 BOTTLE (45963-439-65)	946 ml	2011-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
(Lactulose Solution USP, 10 g/15 mL)	Actavis Pharma, Inc. \| Fresenius Kabi Austria GmbH	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	6
(Lactulose Solution USP, 10 g/15 mL)	A-S Medication Solutions	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	4