Home NDC 29300-220 montelukast sodium
Product NDC 29300-220
11-digit product format 293000220
Labeler code 29300
Product ID 29300-220_57f07f65-1a14-4423-9da8-975664ca0684
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name montelukast sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
Application ANDA204290
Marketing category ANDA
Marketing start 2016-01-01
Substance MONTELUKAST SODIUM
Active strength 10 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 42 .
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 A204290-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204290-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 10 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200224 Internal RxNorm lookup 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 29300-220-01 montelukast sodium 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 17 29300-220-10 montelukast sodium 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 17 29300-220-13 montelukast sodium 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 17 29300-220-19 montelukast sodium 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29300-220 MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [UNICHEM PHARMACEUTICALS (USA), INC.] 17 Current NDC, Legacy NDC, 4 package rows 20230625_9e375c07-70db-458c-9336-22a7037b0a5f.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join montelukast sodium MONTELUKAST SODIUM Preferred Pharmaceuticals Inc. 1eeb3123-9e93-4681-8096-800a7c7acf8a 2026-07-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204290 application number: ANDA204290 montelukast sodium MONTELUKAST SODIUM NuCare Pharmaceuticals,Inc. a7c11cbe-0834-27a5-e053-2995a90ac43f 2024-12-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204290 application number: ANDA204290 montelukast sodium MONTELUKAST SODIUM Bryant Ranch Prepack 9beb1510-f3af-4269-a9d0-e2bd41ac369b 2024-04-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204290 application number: ANDA204290 montelukast sodium MONTELUKAST SODIUM Unichem Pharmaceuticals (USA), Inc. 9e375c07-70db-458c-9336-22a7037b0a5f 2023-06-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204290 application number: ANDA204290 ndc (product): 29300-220 montelukast sodium MONTELUKAST SODIUM Proficient Rx LP 2ce48faf-4504-488a-8b20-3e8d4f008fb2 2022-06-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 204290 application number: ANDA204290
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 29300-220-01 29300022001 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-01) 2016-01-01 0000-00-00 No No Current 29300-220-10 29300022010 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-10) 2016-01-01 0000-00-00 No No Current 29300-220-13 29300022013 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-13) 2016-01-01 0000-00-00 No No Current 29300-220-19 29300022019 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-19) 2016-01-01 0000-00-00 No No Current