Home NDC 65162-772 Montelukast Sodium
Product NDC 65162-772
11-digit product format 651620772
Labeler code 65162
Product ID 65162-772_ed8a8093-3cde-44cf-9bdc-c8bc5fb9909c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Montelukast
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA205107
Marketing category ANDA
Marketing start 2020-09-04
Substance MONTELUKAST SODIUM
Active strength 5 mg/1
Pharmacologic classes Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205107-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2020-09-04 A205107-002 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2020-09-04
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 · 74 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 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205107-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205107-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2020-09-04 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Montelukast Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MONTELUKAST SODIUM 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U1O3J18SFL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242438 Internal RxNorm lookup 311759 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 65162-772-03 Montelukast Sodium 30 in 1 BOTTLE TABLET, CHEWABLE 30 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-772 MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE [AMNEAL PHARMACEUTICALS LLC] 20 Current NDC, Legacy NDC, 1 package rows 20250419_bcd49102-a21c-4628-a322-6cdd934e7f09.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 · 1 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 65162-772-03 65162077203 30 TABLET, CHEWABLE in 1 BOTTLE (65162-772-03) 2020-09-04 0000-00-00 No No Current