Nitroglycerin Slocaps

Product NDC: 21695-635
11-digit product format: 216950635
Labeler code: 21695
Product ID: 21695-635_bd2f4e87-e595-4099-acb9-e36803170f72
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitroglycerin Sustained-release capsules
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 1982-08-25
Marketing end: 0000-00-00
Substance: NITROGLYCERIN
Active strength: 3 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	21695-635		I	Inactivated by FDA		2026-08-11
excluded package	package	21695-635	21695-635-60	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 · 44 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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`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	21695-635-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-635-60	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-635-60	`110d247fa046…`	`a55b01930146…`

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
21695-635-60	2019-09-24	C162847	48780-1	934fe258-4d1f-48b1-e053-8cdaa90a720a	Nitroglycerin Slocaps Nitroglycerin Sustained-release Capsules 2.5 mg, 6.5 mg, 9 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-635-60	Nitroglycerin Slocaps	60 in 1 BOTTLE	CAPSULE	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-635-60	EA - Each	21695-635	d53fa24a-166f-46b1-9792-3dd703f7e833	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NITROGLYCERIN	ACTIVE INGREDIENT	G59M7S0WS3	NITROGLYCERIN SLOCAPS (NITROGLYCERIN SUSTAINED-RELEASE CAPSULES) CAPSULE [REBEL DISTRIBUTORS CORP]	1
NITROGLYCERIN	ACTIVE MOIETY	G59M7S0WS3	NITROGLYCERIN SLOCAPS (NITROGLYCERIN SUSTAINED-RELEASE CAPSULES) CAPSULE [REBEL DISTRIBUTORS CORP]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	NITROGLYCERIN SLOCAPS (NITROGLYCERIN SUSTAINED-RELEASE CAPSULES) CAPSULE [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITROGLYCERIN SLOCAPS (NITROGLYCERIN SUSTAINED-RELEASE CAPSULES) CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITROGLYCERIN SLOCAPS (NITROGLYCERIN SUSTAINED-RELEASE CAPSULES) CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	NITROGLYCERIN SLOCAPS (NITROGLYCERIN SUSTAINED-RELEASE CAPSULES) CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NITROGLYCERIN SLOCAPS (NITROGLYCERIN SUSTAINED-RELEASE CAPSULES) CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITROGLYCERIN SLOCAPS (NITROGLYCERIN SUSTAINED-RELEASE CAPSULES) CAPSULE [REBEL DISTRIBUTORS CORP]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	NITROGLYCERIN SLOCAPS (NITROGLYCERIN SUSTAINED-RELEASE CAPSULES) CAPSULE [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITROGLYCERIN SLOCAPS (NITROGLYCERIN SUSTAINED-RELEASE CAPSULES) CAPSULE [REBEL DISTRIBUTORS CORP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	NITROGLYCERIN SLOCAPS (NITROGLYCERIN SUSTAINED-RELEASE CAPSULES) CAPSULE [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITROGLYCERIN SLOCAPS (NITROGLYCERIN SUSTAINED-RELEASE CAPSULES) CAPSULE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-635	NITROGLYCERIN SLOCAPS (NITROGLYCERIN SUSTAINED-RELEASE CAPSULES) CAPSULE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110113_bd2f4e87-e595-4099-acb9-e36803170f72.zip

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
312013	nitroglycerin 2.5 MG Extended Release Oral Capsule	PSN	bd2f4e87-e595-4099-acb9-e36803170f72	1
312018	nitroglycerin 6.5 MG Extended Release Oral Capsule	PSN	bd2f4e87-e595-4099-acb9-e36803170f72	1
312013	nitroglycerin 2.5 MG Extended Release Oral Capsule	SCD	bd2f4e87-e595-4099-acb9-e36803170f72	1
312018	nitroglycerin 6.5 MG Extended Release Oral Capsule	SCD	bd2f4e87-e595-4099-acb9-e36803170f72	1
312013	NTG 2.5 MG Extended Release Oral Capsule	SY	bd2f4e87-e595-4099-acb9-e36803170f72	1
312018	NTG 6.5 MG Extended Release Oral Capsule	SY	bd2f4e87-e595-4099-acb9-e36803170f72	1
312013	TNG 2.5 MG Extended Release Oral Capsule	SY	bd2f4e87-e595-4099-acb9-e36803170f72	1
312018	TNG 6.5 MG Extended Release Oral Capsule	SY	bd2f4e87-e595-4099-acb9-e36803170f72	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-635-60	21695063560	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitroglycerin Sustained-release capsules	Rebel Distributors Corp	2011-01-03	HUMAN PRESCRIPTION DRUG LABEL	1