NITROSTAT

Product NDC: 0404-9800
11-digit product format: 004049800
Labeler code: 0404
Product ID: 0404-9800_32b2fbb8-8769-4399-9cb6-7183cb7072ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitroglycerin tablet
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Henry Schein, Inc.
Application: NDA021134
Marketing category: NDA
Marketing start: 2024-09-17
Substance: NITROGLYCERIN
Active strength: .4 mg/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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021134-001	NITROSTAT	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01
N021134-002	NITROSTAT	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01
N021134-003	NITROSTAT	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021134-001	AB
N021134-002	AB
N021134-003	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 4 · 123 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	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N021134-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021134-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021134-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021134-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021134-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021134-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021134-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021134-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021134-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021134-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021134-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021134-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021134-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021134-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021134-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021134-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021134-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021134-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021134-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021134-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021134-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021134-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021134-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021134-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021134-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021134-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021134-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021134-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021134-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021134-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021134-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021134-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021134-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021134-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021134-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021134-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021134-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021134-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021134-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021134-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROGLYCERIN	.4 mg/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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198039	Internal RxNorm lookup
207346	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
5265648f-3062-48a2-a4e3-fea1207807a8	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
0404-9800-01	NITROSTAT	1 in 1 BAG	TABLET	1		2
0404-9800-01	NITROSTAT	25 in 1 BOTTLE	TABLET	25		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9800	NITROSTAT (NITROGLYCERIN TABLET) TABLET [HENRY SCHEIN, INC.]	1	Current NDC, 2 package rows	20240919_5265648f-3062-48a2-a4e3-fea1207807a8.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROSTAT	NITROGLYCERIN TABLET	Henry Schein, Inc.	5265648f-3062-48a2-a4e3-fea1207807a8	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021134 application number: NDA021134 ndc (product): 0404-9800
NITROGLYCERIN	NITROGLYCERIN	Mylan Pharmaceuticals Inc.	041f127e-5166-4484-bc1a-0a373d1187ae	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021134 application number: NDA021134
NITROSTAT	NITROGLYCERIN	A-S Medication Solutions	f7059ff7-bf74-48b4-811d-6eb1c26bfd8b	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021134 application number: NDA021134
Nitrostat	NITROGLYCERIN	Viatris Specialty LLC	9a52da75-d0af-4237-96c0-0b12adfa8636	2023-02-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021134 application number: NDA021134
Nitrostat	NITROGLYCERIN	Proficient Rx LP	6fe3965f-0dd8-4bae-9771-de25074cb1b0	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021134 application number: NDA021134

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
198039	nitroglycerin 0.4 MG Sublingual Tablet	PSN	5265648f-3062-48a2-a4e3-fea1207807a8	2
207346	Nitrostat 0.4 MG Sublingual Tablet	PSN	5265648f-3062-48a2-a4e3-fea1207807a8	2
207346	nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat]	SBD	5265648f-3062-48a2-a4e3-fea1207807a8	2
198039	nitroglycerin 0.4 MG Sublingual Tablet	SCD	5265648f-3062-48a2-a4e3-fea1207807a8	2
198039	nitroglycerin 400 MCG Sublingual Tablet	SY	5265648f-3062-48a2-a4e3-fea1207807a8	2
207346	Nitrostat 0.4 MG Sublingual Tablet	SY	5265648f-3062-48a2-a4e3-fea1207807a8	2
198039	NTG 0.4 MG Sublingual Tablet	SY	5265648f-3062-48a2-a4e3-fea1207807a8	2
207346	NTG 0.4 MG Sublingual Tablet [Nitrostat]	SY	5265648f-3062-48a2-a4e3-fea1207807a8	2
198039	TNG 0.4 MG Sublingual Tablet	SY	5265648f-3062-48a2-a4e3-fea1207807a8	2
207346	TNG 0.4 MG Sublingual Tablet [Nitrostat]	SY	5265648f-3062-48a2-a4e3-fea1207807a8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0404-9800-01	00404980001	1 BOTTLE in 1 BAG (0404-9800-01) / 25 TABLET in 1 BOTTLE	1 bottle	2024-09-17	No	No	Current