SINGULAIR

Product NDC
78206-171
11-digit product format
782060171
Labeler code
78206
Product ID
78206-171_57a12189-3bb3-4a5d-b5fe-fc57db87c134
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
GRANULE
Route
ORAL
Labeler
Organon LLC
Application
NDA021409
Marketing category
NDA
Marketing start
2021-06-01
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
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021409-001SINGULAIRMONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALRLD2002-07-26

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALRLD2002-07-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-263f01610625f2…
2019-09-15 20:21 UTC2019-09N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021409-001SINGULAIREQ 4MG BASE/PACKETGRANULE / ORALABRLD, RS2002-07-26e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021409-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021409-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021409-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021409-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021409-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021409-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021409-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021409-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021409-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021409-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021409-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021409-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021409-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021409-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021409-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021409-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021409-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021409-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021409-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021409-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021409-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021409-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021409-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021409-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021409-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021409-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021409-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021409-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021409-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021409-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021409-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021409-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021409-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021409-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021409-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021409-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021409-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021409-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021409-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021409-001AB1cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021409-00180078302022-10-24Drug product2011-09-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021409-00180078302022-10-24Drug product2011-09-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021409-00180078302022-10-24Drug product2011-09-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021409-00180078302022-10-24Drug product2011-09-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021409-00180078302022-10-24Drug product2011-09-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021409-00180078302022-10-24Drug product2011-09-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021409-00180078302022-10-24Drug product2011-09-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N021409-00180078302022-10-24Drug product2011-09-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021409-00180078302022-10-24Drug product2011-09-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021409-00180078302022-10-24Drug product2011-09-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021409-00180078302022-10-24Drug product2011-09-293f01610625f2…
2019-09-15 20:21 UTC2019-09N021409-00180078302022-10-24Drug product2011-09-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N021409-00180078302022-10-24Drug product2011-09-29ea99ee380514…
2023-01-26 05:58 UTC2023-01N021409-00180078302022-10-24Drug product2011-09-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021409-00180078302022-10-24Drug product2011-09-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021409-00180078302022-10-24Drug product2011-09-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021409-00180078302022-10-24Drug product2011-09-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021409-00180078302022-10-24Drug product2011-09-29cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST SODIUM4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U1O3J18SFLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
153892Internal RxNorm lookup
153893Internal RxNorm lookup
200224Internal RxNorm lookup
242438Internal RxNorm lookup
261367Internal RxNorm lookup
311759Internal RxNorm lookup
351246Internal RxNorm lookup
404406Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
482dcc92-b47f-4ea6-854a-f5ac2aea7842Available on FDA.report

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
78206-171-01SINGULAIR1 in 1 PACKETGRANULE15
78206-171-01SINGULAIR30 in 1 CARTONGRANULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-171-01EA - Each78206-171adda72a1-10a3-4aa4-aea7-99b6e792daf412021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-171SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [ORGANON LLC]4Current NDC, Legacy NDC, 2 package rows20241017_482dcc92-b47f-4ea6-854a-f5ac2aea7842.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SINGULAIRMONTELUKAST SODIUMOrganon LLC482dcc92-b47f-4ea6-854a-f5ac2aea78422025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021409
application number: NDA021409
ndc (product): 78206-171

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
311759montelukast sodium 4 MG Chewable TabletPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
351246montelukast sodium 4 MG Oral GranulesPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
242438montelukast sodium 5 MG Chewable TabletPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
153892Singulair 10 MG Oral TabletPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
261367Singulair 4 MG Chewable TabletPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
404406Singulair 4 MG Oral GranulesPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
153893Singulair 5 MG Chewable TabletPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
153892montelukast 10 MG Oral Tablet [Singulair]SBD482dcc92-b47f-4ea6-854a-f5ac2aea78425
261367montelukast 4 MG Chewable Tablet [Singulair]SBD482dcc92-b47f-4ea6-854a-f5ac2aea78425
404406montelukast 4 MG Oral Granules [Singulair]SBD482dcc92-b47f-4ea6-854a-f5ac2aea78425
153893montelukast 5 MG Chewable Tablet [Singulair]SBD482dcc92-b47f-4ea6-854a-f5ac2aea78425
200224montelukast 10 MG Oral TabletSCD482dcc92-b47f-4ea6-854a-f5ac2aea78425
311759montelukast 4 MG Chewable TabletSCD482dcc92-b47f-4ea6-854a-f5ac2aea78425
351246montelukast 4 MG Oral GranulesSCD482dcc92-b47f-4ea6-854a-f5ac2aea78425
242438montelukast 5 MG Chewable TabletSCD482dcc92-b47f-4ea6-854a-f5ac2aea78425
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
351246montelukast 4 MG (as montelukast sodium 4.2 MG) Oral GranulesSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
153892Singulair 10 MG (montelukast sodium 10.4 MG) Oral TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
153892Singulair 10 MG Oral TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
261367Singulair 4 MG (montelukast sodium 4.2 MG) Chewable TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
404406Singulair 4 MG (montelukast sodium 4.2 MG) Oral GranulesSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
261367Singulair 4 MG Chewable TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
404406Singulair 4 MG Oral GranulesSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
153893Singulair 5 MG (montelukast sodium 5.2 MG) Chewable TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
153893Singulair 5 MG Chewable TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78206-171-017820601710130 PACKET in 1 CARTON (78206-171-01) / 1 GRANULE in 1 PACKET30 packet2021-06-010000-00-00NoNoCurrent