Home NDC 65862-201-99 Losartan Potassium
Product NDC 65862-201
Requested package NDC 65862-201-99
11-digit product format 658620201
Labeler code 65862
Product ID 65862-201_1942e030-0f36-4f65-9f60-4898439afc61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Losartan Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA090083
Marketing category ANDA
Marketing start 2010-10-06
Substance LOSARTAN POTASSIUM
Active strength 25 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090083-001 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 A090083-002 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 A090083-003 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 132 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 2026-10-15 13:18:30 2026-09 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090083-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2010-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090083-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2010-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090083-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2010-10-06 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Losartan Potassium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOSARTAN POTASSIUM 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3ST302B24A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 979480 Internal RxNorm lookup 979485 Internal RxNorm lookup 979492 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 65862-201-05 Losartan Potassium 500 in 1 BOTTLE TABLET, FILM COATED 500 25 65862-201-30 Losartan Potassium 30 in 1 BOTTLE TABLET, FILM COATED 30 25 65862-201-90 Losartan Potassium 90 in 1 BOTTLE TABLET, FILM COATED 90 25 65862-201-99 Losartan Potassium 1000 in 1 BOTTLE TABLET, FILM COATED 1000 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOSARTAN POTASSIUM ACTIVE INGREDIENT 3ST302B24A LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12 LOSARTAN ACTIVE MOIETY JMS50MPO89 LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12 WATER INACTIVE INGREDIENT 059QF0KO0R LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-201 LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 23 Current NDC, Legacy NDC, 4 package rows 20240529_31366b4b-dfd6-4fda-babe-2cb3d2c14a2b.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 2 of 2 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65862-201-99 65862020199 1000 TABLET, FILM COATED in 1 BOTTLE (65862-201-99) 2010-10-06 0000-00-00 No No Current