Nitrostat

Product NDC: 0071-0419
11-digit product format: 000710419
Labeler code: 0071
Product ID: 0071-0419_b21bdc0d-86ca-4a5f-9695-a7a8064f5bed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitroglycerin
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Parke-Davis Div of Pfizer Inc
Application: NDA021134
Marketing category: NDA
Marketing start: 2000-05-01
Marketing end: 0000-00-00
Substance: NITROGLYCERIN
Active strength: 1 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0071-0419		D	Discontinued by firm		2026-08-11
excluded package	package	0071-0419	0071-0419-24	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0071-0419-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0071-0419-24	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0071-0419-24	EA - Each	0071-0419	4bf2857d-ac7a-4aae-a82b-3ce2128016df	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NITROGLYCERIN	ACTIVE INGREDIENT	G59M7S0WS3	NITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]	8
NITROGLYCERIN	ACTIVE MOIETY	G59M7S0WS3	NITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]	8
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	NITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]	8
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	NITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0071-0419	NITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]	18	Legacy NDC	20240606_79ba021e-183c-4b4d-822e-4ff5ef54ca61.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0071-0419-24	00071041924	1 BOTTLE in 1 CARTON (0071-0419-24) > 100 TABLET in 1 BOTTLE	1 bottle	2000-05-01	0000-00-00	No	No	Current