NITROLINGUAL

Product NDC: 70007-300
11-digit product format: 700070300
Labeler code: 70007
Product ID: 70007-300_806a9c83-efeb-4862-acec-0fc43839e23d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitroglycerin
Dosage form: SPRAY
Route: ORAL
Labeler: Espero Pharmaceuticals, Inc.
Application: NDA018705
Marketing category: NDA
Marketing start: 2016-03-01
Marketing end: 0000-00-00
Substance: NITROGLYCERIN
Active strength: 400 ug/1
Pharmacologic classes: Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70007-300		D	Discontinued by firm	2026-08-17
excluded package	package	70007-300	70007-300-20	D	Discontinued by firm	2026-08-17
excluded package	package	70007-300	70007-300-65	D	Discontinued by firm	2026-08-17

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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70007-300-65	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70007-300-20	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70007-300-20	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70007-300-65	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70007-300-20	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70007-300-65	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70007-300-20	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70007-300-65	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70007-300-20	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70007-300-65	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70007-300-20	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70007-300-65	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70007-300-20	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70007-300-65	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70007-300-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70007-300-65	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70007-300-20	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70007-300-65	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70007-300-20	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70007-300-65	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70007-300-20	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70007-300-65	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70007-300-20	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70007-300-65	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70007-300-20	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70007-300-65	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70007-300-20	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70007-300-65	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70007-300-20	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70007-300-65	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70007-300-65	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70007-300-20	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70007-300-65	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70007-300-20	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70007-300-65	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70007-300-20	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	70007-300-65	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	70007-300-20	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	70007-300-65	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	70007-300-20	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018705-001	NITROLINGUAL	NITROGLYCERIN	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31
N018705-002	NITROLINGUAL PUMPSPRAY	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018705-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11

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 3 · 84 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
2026-08-18 06:07:40	2026-07	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`bb7c543d1eb4…`

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	N018705-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018705-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018705-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018705-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018705-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018705-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018705-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018705-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018705-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018705-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018705-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018705-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018705-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018705-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018705-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018705-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018705-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018705-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018705-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018705-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018705-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018705-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018705-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018705-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018705-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018705-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018705-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018705-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018705-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018705-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018705-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018705-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018705-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018705-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018705-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018705-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018705-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018705-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018705-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018705-002	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`e64feba35796…`

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
00358076-c817-430b-b924-11d717dc307c	Product name	1	20160718
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
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
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70007-300-20	2020-01-31	C162847	48780-1	9d75b9d0-0af3-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NITROLINGUAL® PUMPSPRAY safely and effectively. See full prescribing information for NITROLINGUAL PUMPSPRAY. NITROLINGUAL® PUMPSPRAY (nitroglycerin) lingual spray Initial U.S. Approval: 1997
70007-300-65	2020-01-31	C162847	48780-1	9d75b9d0-0af3-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NITROLINGUAL® PUMPSPRAY safely and effectively. See full prescribing information for NITROLINGUAL PUMPSPRAY. NITROLINGUAL® PUMPSPRAY (nitroglycerin) lingual spray Initial U.S. Approval: 1997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70007-300-20	GM - Gram	70007-300	dd14af1c-5125-42b7-a047-59aa065e2b1a	1	2016-11-08
70007-300-65	GM - Gram	70007-300	35db30df-dee3-4730-9460-a3c8a4d8bc86	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70007-300	NITROLINGUAL (NITROGLYCERIN) SPRAY [ESPERO PHARMACEUTICALS, INC.]	5	Legacy NDC	20180809_2b7c772a-adef-4eef-bb83-aaa798e1b712.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
NITROGLYCERIN LINGUAL	NITROGLYCERIN	Allegis Pharmaceuticals, LLC	fadd07b7-189b-4678-ad0f-bf1e4d3d1300	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018705 application number: NDA018705
NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	422b4713-9531-f1bf-e063-6294a90ada2b	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018705 application number: NDA018705
NITROLINGUAL	NITROGLYCERIN	INDEPENDENCE PHARMACEUTICALS, LLC	d19b5f51-ca85-48d6-9ccd-8ae26249cdc3	2024-05-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018705 application number: NDA018705
NITROGLYCERIN LINGUAL	NITROGLYCERIN LINGUAL	HF Acquisition Co LLC, DBA HealthFirst	a8eb91f6-7f2e-7d57-e053-2995a90a3893	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018705 application number: NDA018705
Nitroglycerin	NITROGLYCERIN	Prasco Laboratories	f9731c86-34b0-42a2-8b39-eca907e02e74	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018705 application number: NDA018705