Home NDC 29300-221 montelukast sodium
Product NDC 29300-221
11-digit product format 293000221
Labeler code 29300
Product ID 29300-221_c2311308-5e7d-44e4-91b7-5a6d653be28f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name montelukast sodium
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
Application ANDA208621
Marketing category ANDA
Marketing start 2018-08-20
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 44 .
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 A208621-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 A208621-002 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02
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 · 88 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 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2018-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208621-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208621-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2018-07-02 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 48 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 montelukast sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MONTELUKAST SODIUM 4 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 29300-221-10 montelukast sodium 1000 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 1000 17 29300-221-13 montelukast sodium 30 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 30 17 29300-221-19 montelukast sodium 90 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 90 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29300-221 MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [UNICHEM PHARMACEUTICALS (USA), INC.] 17 Current NDC, Legacy NDC, 3 package rows 20230625_9e375c07-70db-458c-9336-22a7037b0a5f.zip
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 29300-221-10 29300022110 1000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-221-10) 2018-08-20 0000-00-00 No No Current 29300-221-13 29300022113 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-221-13) 2018-08-20 0000-00-00 No No Current 29300-221-19 29300022119 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-221-19) 2018-08-20 0000-00-00 No No Current