NITROGLYCERIN LINGUAL

Product NDC: 51662-1423
11-digit product format: 516621423
Labeler code: 51662
Product ID: 51662-1423_2b37cac2-b279-2c5d-e063-6394a90a9ede
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NITROGLYCERIN LINGUAL
Dosage form: SPRAY
Route: ORAL
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA091496
Marketing category: ANDA
Marketing start: 2019-10-09
Substance: NITROGLYCERIN
Active strength: 400 ug/1
Pharmacologic classes: Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091496-001	NITROGLYCERIN	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB		2013-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091496-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091496-001	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	2013-09-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091496-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091496-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091496-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091496-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091496-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091496-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091496-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091496-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091496-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091496-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091496-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091496-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091496-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091496-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091496-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091496-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091496-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091496-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091496-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091496-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091496-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091496-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091496-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091496-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091496-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091496-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091496-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091496-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091496-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091496-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091496-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091496-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091496-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091496-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091496-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091496-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091496-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091496-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091496-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091496-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: NITROGLYCERIN LINGUAL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROGLYCERIN	400 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G59M7S0WS3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
705129	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
9483ea48-0b1e-68c0-e053-2995a90a84d5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7480e90b-004b-ebe4-2243-4f2fefdd9e78	Product name	2	20260128
3f158398-73f2-4b90-47d1-5c60e8719a98	Product name	9	20250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0	Product name	2	20250117
00358076-c817-430b-b924-11d717dc307c	Product name	1	20160718
669af5aa-14f3-3df7-f100-5f580ffd43c1	Product name	1	20140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fb	Product name	1	20140508
8bb82a1c-d0d0-fc27-011f-172e545f0382	Product name	1	20140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51662-1423-1	NITROGLYCERIN LINGUAL	60 in 1 BOTTLE	SPRAY	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1423	NITROGLYCERIN LINGUAL SPRAY [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	3	Current NDC, Legacy NDC, 1 package rows	20250110_9483ea48-0b1e-68c0-e053-2995a90a84d5.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROGLYCERIN LINGUAL	NITROGLYCERIN LINGUAL	HF Acquisition Co LLC, DBA HealthFirst	947e4e68-ef8a-6c63-e053-2a95a90ac193	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091496 application number: ANDA091496
NITROGLYCERIN LINGUAL	NITROGLYCERIN LINGUAL	HF Acquisition Co LLC, DBA HealthFirst	9483ea48-0b1e-68c0-e053-2995a90a84d5	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091496 application number: ANDA091496 ndc (product): 51662-1423
nitroglycerin lingual	NITROGLYCERIN	Padagis Israel Pharmaceuticals Ltd	e7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091496 application number: ANDA091496

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G59M7S0WS3	NITROGLYCERIN	55-63-0	NITROGLYCERIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
705129	nitroglycerin 400 MCG/ACTUAT Mucosal Spray	PSN	9483ea48-0b1e-68c0-e053-2995a90a84d5	3
705129	nitroglycerin 0.4 MG/ACTUAT Mucosal Spray	SCD	9483ea48-0b1e-68c0-e053-2995a90a84d5	3
705129	nitroglycerin 400 MCG/ACTUAT Mucosal Spray	SY	9483ea48-0b1e-68c0-e053-2995a90a84d5	3
705129	nitroglycerin 400 MCG/ACTUAT Oral Spray	SY	9483ea48-0b1e-68c0-e053-2995a90a84d5	3
705129	nitroglycerin 400 MCG/ACTUAT Sublingual Spray	SY	9483ea48-0b1e-68c0-e053-2995a90a84d5	3
705129	NTG 0.4 MG/ACTUAT Mucosal Spray	SY	9483ea48-0b1e-68c0-e053-2995a90a84d5	3
705129	TNG 0.4 MG/ACTUAT Mucosal Spray	SY	9483ea48-0b1e-68c0-e053-2995a90a84d5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1423-1	51662142301	60 SPRAY in 1 BOTTLE (51662-1423-1)	60 spray	2019-10-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NITROGLYCERIN LINGUAL SPRAY 400mcg PER SPRAY 60 METERED SPRAYS 4.9g NET CONTENTS UNBOXED	HF Acquisition Co LLC, DBA HealthFirst	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	3