Home NDC 71610-805 ALLI
Product NDC 71610-805
11-digit product format 716100805
Labeler code 71610
Product ID 71610-805_14a73146-26ef-3d96-e063-6394a90ab4ce
Type HUMAN OTC DRUG
Nonproprietary name orlistat
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, 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 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 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 Product TE source text 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 2026-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-805-34 ALLI 2280 in 1 BOTTLE CAPSULE 2280 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-805 ALLI (ORLISTAT) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] 1 Current NDC, 1 package rows 20240330_14a75092-f910-53df-e063-6294a90acc66.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 Sample Exclude flag Status 71610-805-34 71610080534 2280 CAPSULE in 1 BOTTLE (71610-805-34) 2280 capsule 2024-03-22 No No Current