SINGULAIR

Product NDC: 78206-172
11-digit product format: 782060172
Labeler code: 78206
Product ID: 78206-172_57a12189-3bb3-4a5d-b5fe-fc57db87c134
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: montelukast sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Organon LLC
Application: NDA020829
Marketing category: NDA
Marketing start: 2021-06-01
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 1.

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
N020829-002	SINGULAIR	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020829-002	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 · 41 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	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020829-002	SINGULAIR	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020829-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020829-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020829-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020829-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020829-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020829-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020829-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020829-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020829-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020829-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020829-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020829-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020829-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020829-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020829-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020829-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020829-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020829-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020829-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020829-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020829-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020829-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020829-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020829-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020829-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020829-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020829-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020829-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020829-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020829-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020829-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020829-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020829-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020829-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020829-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020829-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020829-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020829-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020829-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020829-002	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: SINGULAIR
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 · 8 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
482dcc92-b47f-4ea6-854a-f5ac2aea7842	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
8d8a355b-240d-8c38-7331-c9e3c1068a33	Product name	9	20161220
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78206-172-01	SINGULAIR	30 in 1 BOTTLE	TABLET, FILM COATED	30		5
78206-172-02	SINGULAIR	90 in 1 BOTTLE	TABLET, FILM COATED	90		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
78206-172-01	EA - Each	78206-172	5a59402b-deaf-470e-82ae-7c9f182ae686	1	2021-08-05
78206-172-02	EA - Each	78206-172	15670ffd-60c9-4819-a895-f3f61ced3ae5	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78206-172	SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [ORGANON LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241017_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SINGULAIR	MONTELUKAST SODIUM	Organon LLC	482dcc92-b47f-4ea6-854a-f5ac2aea7842	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020829 application number: NDA020829 ndc (product): 78206-172

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U1O3J18SFL	MONTELUKAST SODIUM	151767-02-1	MONTELUKAST SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200224	montelukast sodium 10 MG Oral Tablet	PSN	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
311759	montelukast sodium 4 MG Chewable Tablet	PSN	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
351246	montelukast sodium 4 MG Oral Granules	PSN	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
242438	montelukast sodium 5 MG Chewable Tablet	PSN	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
153892	Singulair 10 MG Oral Tablet	PSN	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
261367	Singulair 4 MG Chewable Tablet	PSN	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
404406	Singulair 4 MG Oral Granules	PSN	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
153893	Singulair 5 MG Chewable Tablet	PSN	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
153892	montelukast 10 MG Oral Tablet [Singulair]	SBD	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
261367	montelukast 4 MG Chewable Tablet [Singulair]	SBD	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
404406	montelukast 4 MG Oral Granules [Singulair]	SBD	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
153893	montelukast 5 MG Chewable Tablet [Singulair]	SBD	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
200224	montelukast 10 MG Oral Tablet	SCD	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
311759	montelukast 4 MG Chewable Tablet	SCD	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
351246	montelukast 4 MG Oral Granules	SCD	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
242438	montelukast 5 MG Chewable Tablet	SCD	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
311759	montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable Tablet	SY	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
351246	montelukast 4 MG (as montelukast sodium 4.2 MG) Oral Granules	SY	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
153892	Singulair 10 MG (montelukast sodium 10.4 MG) Oral Tablet	SY	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
153892	Singulair 10 MG Oral Tablet	SY	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
261367	Singulair 4 MG (montelukast sodium 4.2 MG) Chewable Tablet	SY	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
404406	Singulair 4 MG (montelukast sodium 4.2 MG) Oral Granules	SY	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
261367	Singulair 4 MG Chewable Tablet	SY	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
404406	Singulair 4 MG Oral Granules	SY	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
153893	Singulair 5 MG (montelukast sodium 5.2 MG) Chewable Tablet	SY	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5
153893	Singulair 5 MG Chewable Tablet	SY	482dcc92-b47f-4ea6-854a-f5ac2aea7842	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
78206-172-01	78206017201	30 TABLET, FILM COATED in 1 BOTTLE (78206-172-01)	2021-06-01	0000-00-00	No	No	Current
78206-172-02	78206017202	90 TABLET, FILM COATED in 1 BOTTLE (78206-172-02)	2021-06-01	0000-00-00	No	No	Current