ALLI

Product NDC: 0135-0461
Requested package NDC: 0135-0461-07
11-digit product format: 001350461
Labeler code: 0135
Product ID: 0135-0461_4d51b8f1-a819-7ff6-e063-6294a90a82bc
Type: HUMAN OTC DRUG
Nonproprietary name: orlistat
Dosage form: CAPSULE
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: NDA021887
Marketing category: NDA
Marketing start: 2007-02-07
Substance: ORLISTAT
Active strength: 60 mg/1
Pharmacologic classes: Intestinal Lipase Inhibitor [EPC], Lipase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0135-0461	0135-0461-07	D	Discontinued by firm		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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0135-0461	0135-0461-07	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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
N021887-001	ALLI	ORLISTAT	60MG	CAPSULE / ORAL		RLD, RS	2007-02-07

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: ALLI
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ORLISTAT	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
95M8R751W8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
692876	Internal RxNorm lookup
723846	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
a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
b3f93084-d1af-0d2d-125b-736522e0a7a2	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0135-0461-01	2020-11-09	Drug Facts
0135-0461-02	2020-11-09	Drug Facts
0135-0461-03	2020-11-09	Drug Facts
0135-0461-05	2020-11-09	Drug Facts
0135-0461-06	2020-11-09	Drug Facts
0135-0461-07	2020-11-09	Drug Facts
0135-0461-08	2020-11-09	Drug Facts
0135-0461-01	2020-01-31	Drug Facts
0135-0461-02	2020-01-31	Drug Facts
0135-0461-03	2020-01-31	Drug Facts
0135-0461-05	2020-01-31	Drug Facts
0135-0461-06	2020-01-31	Drug Facts
0135-0461-07	2020-01-31	Drug Facts
0135-0461-08	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0135-0461-01	ALLI	60 in 1 BOTTLE	CAPSULE	60	15
0135-0461-02	ALLI	90 in 1 BOTTLE	CAPSULE	90	15
0135-0461-03	ALLI	120 in 1 BOTTLE	CAPSULE	120	15
0135-0461-05	ALLI	120 in 1 BOTTLE	CAPSULE	120	15
0135-0461-06	ALLI	170 in 1 BOTTLE	CAPSULE	170	15
0135-0461-07	ALLI	21 in 1 BOTTLE	CAPSULE	21	15
0135-0461-08	ALLI	2 in 1 CARTON	CAPSULE	2	15
0135-0461-08	ALLI	60 in 1 BOTTLE	CAPSULE	60	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0461-01	EA - Each	0135-0461	060dcda2-78a0-40a4-9c3b-e21127b35e63	1	2021-05-05
0135-0461-02	EA - Each	0135-0461	b587d8e8-bdf7-455b-a8dd-f9538f9cf317	1	2012-07-24
0135-0461-05	EA - Each	0135-0461	61e49d90-2834-484b-b6cb-3acf721107ed	1	2012-07-24
0135-0461-06	EA - Each	0135-0461	62c7e670-db2d-4367-b445-42e246996c21	1	2012-07-24
0135-0461-07	EA - Each	0135-0461	59c364d2-2aa2-497a-8993-7ff5e80e723f	1	2024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ORLISTAT	ACTIVE INGREDIENT	95M8R751W8	ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
ORLISTAT	ACTIVE MOIETY	95M8R751W8	ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
FERROUS OXIDE	INACTIVE INGREDIENT	G7036X8B5H	ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0461	ALLI (ORLISTAT) CAPSULE [HALEON US HOLDINGS LLC]	14	Current NDC, Legacy NDC, 8 package rows	20240117_a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALLI	ORLISTAT	Haleon US Holdings LLC	a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f	2026-03-18	Warnings	Exact identifier application applno (NDA): 021887 application number: NDA021887 ndc (package): 0135-0461-07 ndc (product): 0135-0461 ndc11 (package): 00135046107
ALLI	ORLISTAT	Aphena Pharma Solutions - Tennessee, LLC	14a75092-f910-53df-e063-6294a90acc66	2024-03-27	Warnings	Exact identifier application applno (NDA): 021887 application number: NDA021887

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
95M8R751W8	ORLISTAT	96829-58-2	ORLISTAT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
723846	Alli 60 MG Oral Capsule	PSN	a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f	15
692876	orlistat 60 MG Oral Capsule	PSN	a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f	15
723846	orlistat 60 MG Oral Capsule [Alli]	SBD	a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f	15
692876	orlistat 60 MG Oral Capsule	SCD	a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f	15
723846	Alli 60 MG Oral Capsule	SY	a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f	15
723846	Alli 60 MG Oral Capsule	PSN	14a75092-f910-53df-e063-6294a90acc66	1
692876	orlistat 60 MG Oral Capsule	PSN	14a75092-f910-53df-e063-6294a90acc66	1
723846	orlistat 60 MG Oral Capsule [Alli]	SBD	14a75092-f910-53df-e063-6294a90acc66	1
692876	orlistat 60 MG Oral Capsule	SCD	14a75092-f910-53df-e063-6294a90acc66	1
723846	Alli 60 MG Oral Capsule	SY	14a75092-f910-53df-e063-6294a90acc66	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-0461-07	00135046107	21 CAPSULE in 1 BOTTLE (0135-0461-07)	21 capsule	2007-02-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Haleon US Holdings LLC	2026-03-18	HUMAN OTC DRUG LABEL	15
Drug Facts	Aphena Pharma Solutions - Tennessee, LLC	2024-03-27	HUMAN OTC DRUG LABEL	1