Nitro-Time

Product NDC: 0904-0647
11-digit product format: 009040647
Labeler code: 0904
Product ID: 0904-0647_468a3460-7923-44c1-bb45-4fcc9a3811d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitroglycerin
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2004-01-29
Marketing end: 2022-12-31
Substance: NITROGLYCERIN
Active strength: 9 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0904-0647		D	Discontinued by firm	2026-08-11
excluded package	package	0904-0647	0904-0647-52	D	Discontinued by firm	2026-08-11
excluded package	package	0904-0647	0904-0647-60	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 · 36 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	0904-0647-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-0647-60	`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	0904-0647-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-0647-60	`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	0904-0647-52	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-0647-60	`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	0904-0647-52	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-0647-60	`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	0904-0647-52	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-0647-60	`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	0904-0647-52	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-0647-60	`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	0904-0647-52	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-0647-60	`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	0904-0647-52	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0904-0647-60	`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	0904-0647-52	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0904-0647-60	`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	0904-0647-52	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0904-0647-60	`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	0904-0647-52	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0904-0647-60	`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	0904-0647-52	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0904-0647-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-0647-52	EA - Each	0904-0647	ede65180-8878-4ab3-bc32-e70316a2a13e	1	2013-02-13
0904-0647-60	EA - Each	0904-0647	251bdc3c-f3da-487c-a2c4-b3a890f6f5b6	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NITROGLYCERIN	ACTIVE INGREDIENT	G59M7S0WS3	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
NITROGLYCERIN	ACTIVE MOIETY	G59M7S0WS3	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
NITROGLYCERIN	ACTIVE INGREDIENT	G59M7S0WS3	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
NITROGLYCERIN	ACTIVE MOIETY	G59M7S0WS3	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
ACETYLATED SUCROSE DISTEARATE	INACTIVE INGREDIENT	XLW9XG1719	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]	1

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
312020	nitroglycerin 9 MG Extended Release Oral Capsule	PSN	d308e2b0-9526-4efc-9566-a33717a87bcc	4
312020	nitroglycerin 9 MG Extended Release Oral Capsule	SCD	d308e2b0-9526-4efc-9566-a33717a87bcc	4
312020	NTG 9 MG Extended Release Oral Capsule	SY	d308e2b0-9526-4efc-9566-a33717a87bcc	4
312020	TNG 9 MG Extended Release Oral Capsule	SY	d308e2b0-9526-4efc-9566-a33717a87bcc	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-0647-52	00904064752	60 CAPSULE in 1 BOTTLE, PLASTIC (0904-0647-52)	60 capsule	2004-01-29	2022-12-31	No	No	Current
0904-0647-60	00904064760	100 CAPSULE in 1 BOTTLE, PLASTIC (0904-0647-60)	100 capsule	2004-01-29	2022-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NITROGLYCERIN EXTENDED-RELEASE CAPSULES	Major Pharmaceuticals	2020-01-24	HUMAN PRESCRIPTION DRUG LABEL	2
Nitroglycerin	Carilion Materials Management	2018-02-06	HUMAN PRESCRIPTION DRUG LABEL	4