Home NDC 43063-381 Montelukast Sodium
Product NDC 43063-381
11-digit product format 430630381
Labeler code 43063
Product ID 43063-381_509acd9d-2a2a-42e5-e063-6294a90a5b42
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Montelukast Sodium
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA090984
Marketing category ANDA
Marketing start 2012-08-03
Substance MONTELUKAST SODIUM
Active strength 4 mg/1
Pharmacologic classes Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090984-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 A090984-002 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090984-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090984-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2012-08-03 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Montelukast Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MONTELUKAST SODIUM 4 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 43063-381-21 Montelukast Sodium 21 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 21 27 43063-381-30 Montelukast Sodium 30 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 30 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MONTELUKAST SODIUM ACTIVE INGREDIENT U1O3J18SFL MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] 7 MONTELUKAST ACTIVE MOIETY MHM278SD3E MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] 7 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] 7 CHERRY INACTIVE INGREDIENT BUC5I9595W MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] 7 MANNITOL INACTIVE INGREDIENT 3OWL53L36A MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-381 MONTELUKAST SODIUM TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] 25 Current NDC, Legacy NDC, 2 package rows 20250110_c69ab399-8ea6-4002-9271-b6a57c862b14.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 · 3 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 43063-381-21 43063038121 21 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-21) 2015-11-05 0000-00-00 No No Current 43063-381-30 43063038130 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-30) 2015-11-05 0000-00-00 No No Current