Nitrostat

Product NDC: 70385-2014
11-digit product format: 703852014
Labeler code: 70385
Product ID: 70385-2014_8117f22a-3a4c-c5a3-e053-2991aa0ac782
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitroglycerin
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Sina Health Inc
Application: NDA021134
Marketing category: NDA
Marketing start: 2000-05-01
Marketing end: 0000-00-00
Substance: NITROGLYCERIN
Active strength: 0 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	70385-2014		I	Inactivated by FDA		2026-08-11
excluded package	package	70385-2014	70385-2014-1	I	Inactivated by FDA		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 · 40 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	70385-2014-1	`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	70385-2014-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70385-2014-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70385-2014-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70385-2014-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70385-2014-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70385-2014-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70385-2014-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70385-2014-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70385-2014-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70385-2014-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70385-2014-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70385-2014-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70385-2014-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70385-2014-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70385-2014-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70385-2014-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70385-2014-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	70385-2014-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	70385-2014-1	`e2bbac7714bc…`	`27bdfed8d636…`

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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70385-2014-1	2020-09-27	C162847	48780-1	ab0e2407-34b2-f274-e053-dbdaa90a6471	Nitrostat ® (Nitroglycerin Sublingual Tablets, USP)
70385-2014-1	2020-09-25	C162847	48780-1	ab0e2407-34b2-f274-e053-dbdaa90a6471	Nitrostat ® (Nitroglycerin Sublingual Tablets, USP)
70385-2014-1	2020-07-22	C162847	48780-1	ab0e2407-34b2-f274-e053-dbdaa90a6471	Nitrostat ® (Nitroglycerin Sublingual Tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70385-2014-1	Nitrostat	25 in 1 BOTTLE	TABLET	25		3
70385-2014-1	Nitrostat	1 in 1 BAG	TABLET	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70385-2014	NITROSTAT (NITROGLYCERIN) TABLET [SINA HEALTH INC]	3	Legacy NDC, 2 package rows	20190205_2d4165c3-169d-5af8-e054-00144ff8d46c.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198039	nitroglycerin 0.4 MG Sublingual Tablet	PSN	2d4165c3-169d-5af8-e054-00144ff8d46c	3
207346	Nitrostat 0.4 MG Sublingual Tablet	PSN	2d4165c3-169d-5af8-e054-00144ff8d46c	3
207346	nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat]	SBD	2d4165c3-169d-5af8-e054-00144ff8d46c	3
198039	nitroglycerin 0.4 MG Sublingual Tablet	SCD	2d4165c3-169d-5af8-e054-00144ff8d46c	3
198039	nitroglycerin 400 MCG Sublingual Tablet	SY	2d4165c3-169d-5af8-e054-00144ff8d46c	3
207346	Nitrostat 0.4 MG Sublingual Tablet	SY	2d4165c3-169d-5af8-e054-00144ff8d46c	3
198039	NTG 0.4 MG Sublingual Tablet	SY	2d4165c3-169d-5af8-e054-00144ff8d46c	3
207346	NTG 0.4 MG Sublingual Tablet [Nitrostat]	SY	2d4165c3-169d-5af8-e054-00144ff8d46c	3
198039	TNG 0.4 MG Sublingual Tablet	SY	2d4165c3-169d-5af8-e054-00144ff8d46c	3
207346	TNG 0.4 MG Sublingual Tablet [Nitrostat]	SY	2d4165c3-169d-5af8-e054-00144ff8d46c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
70385-2014-1	70385201401	25 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrostat ® (Nitroglycerin Sublingual Tablets, USP)	Sina Health Inc	2019-02-04	HUMAN PRESCRIPTION DRUG LABEL	3