FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
montelukast sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui200224, 242438, 311759

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-220-01montelukast sodium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10017
29300-220-10montelukast sodium1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100017
29300-220-13montelukast sodium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3017
29300-220-19montelukast sodium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-220-10EA - Each29300-2203ad1e7c8-7ab6-419e-9d9f-5e9ca624d3dc12016-04-04
29300-220-13EA - Each29300-220517fdabd-5204-42ee-b436-161d898b32a112016-04-04
29300-220-19EA - Each29300-2205f805cd5-7394-4785-8ef9-90e92414608912016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-220MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [UNICHEM PHARMACEUTICALS (USA), INC.]17Current NDC, Legacy NDC, 4 package rows20230625_9e375c07-70db-458c-9336-22a7037b0a5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN9beb1510-f3af-4269-a9d0-e2bd41ac369b102
200224montelukast 10 MG Oral TabletSCD9beb1510-f3af-4269-a9d0-e2bd41ac369b102
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY9beb1510-f3af-4269-a9d0-e2bd41ac369b102
200224montelukast sodium 10 MG Oral TabletPSN9e375c07-70db-458c-9336-22a7037b0a5f17
311759montelukast sodium 4 MG Chewable TabletPSN9e375c07-70db-458c-9336-22a7037b0a5f17
242438montelukast sodium 5 MG Chewable TabletPSN9e375c07-70db-458c-9336-22a7037b0a5f17
200224montelukast 10 MG Oral TabletSCD9e375c07-70db-458c-9336-22a7037b0a5f17
311759montelukast 4 MG Chewable TabletSCD9e375c07-70db-458c-9336-22a7037b0a5f17
242438montelukast 5 MG Chewable TabletSCD9e375c07-70db-458c-9336-22a7037b0a5f17
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY9e375c07-70db-458c-9336-22a7037b0a5f17
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY9e375c07-70db-458c-9336-22a7037b0a5f17
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY9e375c07-70db-458c-9336-22a7037b0a5f17
200224montelukast sodium 10 MG Oral TabletPSN5b500ba9-8a81-4034-beee-86846c561fbe13
200224montelukast 10 MG Oral TabletSCD5b500ba9-8a81-4034-beee-86846c561fbe13
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY5b500ba9-8a81-4034-beee-86846c561fbe13
200224montelukast sodium 10 MG Oral TabletPSNa7c11cbe-0834-27a5-e053-2995a90ac43f6
200224montelukast 10 MG Oral TabletSCDa7c11cbe-0834-27a5-e053-2995a90ac43f6
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYa7c11cbe-0834-27a5-e053-2995a90ac43f6
200224montelukast sodium 10 MG Oral TabletPSN9b560283-cfa3-4289-b4cc-3f1237e668c35
200224montelukast 10 MG Oral TabletSCD9b560283-cfa3-4289-b4cc-3f1237e668c35
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY9b560283-cfa3-4289-b4cc-3f1237e668c35
200224montelukast sodium 10 MG Oral TabletPSN2ce48faf-4504-488a-8b20-3e8d4f008fb24
200224montelukast 10 MG Oral TabletSCD2ce48faf-4504-488a-8b20-3e8d4f008fb24
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY2ce48faf-4504-488a-8b20-3e8d4f008fb24
200224montelukast sodium 10 MG Oral TabletPSN1eeb3123-9e93-4681-8096-800a7c7acf8a2
200224montelukast sodium 10 MG Oral TabletPSN35c1f830-7872-4654-a13e-33c63b5384982
200224montelukast 10 MG Oral TabletSCD35c1f830-7872-4654-a13e-33c63b5384982
200224montelukast 10 MG Oral TabletSCD1eeb3123-9e93-4681-8096-800a7c7acf8a2
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY35c1f830-7872-4654-a13e-33c63b5384982
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY1eeb3123-9e93-4681-8096-800a7c7acf8a2
200224montelukast sodium 10 MG Oral TabletPSN59b9449b-3acf-39f7-e053-2a91aa0a6db21
200224montelukast sodium 10 MG Oral TabletPSN28881947-535f-e3de-e063-6394a90a0caf1
200224montelukast sodium 10 MG Oral TabletPSNea764c40-6647-3f9f-e053-2a95a90a42391
200224montelukast 10 MG Oral TabletSCD59b9449b-3acf-39f7-e053-2a91aa0a6db21
200224montelukast 10 MG Oral TabletSCD28881947-535f-e3de-e063-6394a90a0caf1
200224montelukast 10 MG Oral TabletSCDea764c40-6647-3f9f-e053-2a95a90a42391
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY59b9449b-3acf-39f7-e053-2a91aa0a6db21
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY28881947-535f-e3de-e063-6394a90a0caf1
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYea764c40-6647-3f9f-e053-2a95a90a42391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-220-0129300022001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-01) 2016-01-010000-00-00NoNoCurrent
29300-220-10293000220101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-10) 2016-01-010000-00-00NoNoCurrent
29300-220-132930002201330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-13) 2016-01-010000-00-00NoNoCurrent
29300-220-192930002201990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-19) 2016-01-010000-00-00NoNoCurrent