Enulose

Product NDC: 63629-8800
11-digit product format: 636298800
Labeler code: 63629
Product ID: 63629-8800_29413ce2-7389-4c44-a4b1-f424ac86024f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lactulose
Dosage form: SOLUTION
Route: ORAL; RECTAL
Labeler: Bryant Ranch Prepack
Application: ANDA090502
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
A090502-001	LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	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
A090502-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA		2012-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA		2012-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA		2012-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA		2012-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	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	A090502-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090502-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090502-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090502-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090502-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090502-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090502-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090502-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090502-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090502-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090502-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090502-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090502-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090502-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090502-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090502-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090502-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090502-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090502-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090502-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090502-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090502-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090502-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090502-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090502-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090502-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090502-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090502-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090502-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090502-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090502-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090502-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090502-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090502-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090502-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090502-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090502-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090502-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090502-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090502-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Enulose
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
755470	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
fa3aae7c-6f98-4fbb-85dc-32affe9874d5	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
63629-8800-1	Enulose	473 mL in 1 BOTTLE	SOLUTION	473		103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8800-1	ML - Milliliter	63629-8800	a9740cca-780b-47e5-9e70-b4b84d1b1659	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8800	ENULOSE (LACTULOSE) SOLUTION [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 1 package rows	20241220_fa3aae7c-6f98-4fbb-85dc-32affe9874d5.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enulose	LACTULOSE	Bryant Ranch Prepack	fa3aae7c-6f98-4fbb-85dc-32affe9874d5	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090502 application number: ANDA090502 ndc (product): 63629-8800
Lactulose	LACTULOSE	Fresenius Kabi Austria GmbH	a89835c9-8ce5-4627-8d7d-70ff175b2e07	2022-11-09	Adverse reactions	Exact identifier application applno (ANDA): 090502 application number: ANDA090502
Enulose	LACTULOSE	Actavis Pharma, Inc.	00c42c5c-d19e-4130-aa08-a8bbd47d3e5b	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090502 application number: ANDA090502

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
755470	Enulose 10 GM in 15 mL Oral Solution	PSN	fa3aae7c-6f98-4fbb-85dc-32affe9874d5	103
391937	lactulose 10 GM in 15 mL Oral Solution	PSN	fa3aae7c-6f98-4fbb-85dc-32affe9874d5	103
755470	lactulose 667 MG/ML Oral Solution [Enulose]	SBD	fa3aae7c-6f98-4fbb-85dc-32affe9874d5	103
391937	lactulose 667 MG/ML Oral Solution	SCD	fa3aae7c-6f98-4fbb-85dc-32affe9874d5	103
755470	Enulose 10 GM per 15 ML Syrup	SY	fa3aae7c-6f98-4fbb-85dc-32affe9874d5	103
755470	Enulose 667 MG/ML Oral Solution	SY	fa3aae7c-6f98-4fbb-85dc-32affe9874d5	103
391937	lactulose 10 GM per 15 ML Oral Solution	SY	fa3aae7c-6f98-4fbb-85dc-32affe9874d5	103
391937	lactulose 20 GM per 30 ML Oral Solution	SY	fa3aae7c-6f98-4fbb-85dc-32affe9874d5	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8800-1	63629880001	473 mL in 1 BOTTLE (63629-8800-1)	473 ml	2021-09-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Enulose (Lactulose Solution USP, 10 g/15 mL)	Bryant Ranch Prepack	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	103