Home NDC 61269-460 Xenical
Product NDC 61269-460
11-digit product format 612690460
Labeler code 61269
Product ID 61269-460_4fd710c5-6147-498a-ade9-0cce6e1513c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name orlistat
Dosage form CAPSULE
Route ORAL
Labeler H2-Pharma LLC
Application NDA020766
Marketing category NDA
Marketing start 2010-12-17
Substance ORLISTAT
Active strength 120 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 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 N020766-001 XENICAL ORLISTAT 120MG CAPSULE / ORAL RLD, RS 1999-04-23
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 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020766-001 XENICAL 120MG CAPSULE / ORAL RLD, RS 1999-04-23 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Xenical
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ORLISTAT 120 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 226917 Internal RxNorm lookup 314153 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61269-460-90 Xenical 90 in 1 BOTTLE, PLASTIC CAPSULE 90 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61269-460 XENICAL (ORLISTAT) CAPSULE [H2-PHARMA LLC] 9 Current NDC, Legacy NDC, 1 package rows 20240709_6240792b-9224-2d10-e053-2a91aa0a2c3e.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61269-460-90 61269046090 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-460-90) 90 capsule 2010-12-17 0000-00-00 No No Current