FDA.reportPublic FDA data

Nitro-Time

Product NDC
0904-0643
Requested package NDC
0904-0643-52
11-digit product format
009040643
Labeler code
0904
Product ID
0904-0643_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
2022-10-31
Substance
NITROGLYCERIN
Active strength
3 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0904-06430904-0643-52DDiscontinued by firm2026-08-17

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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-0643-52EA - Each0904-0643d0a5093b-f7f8-4c8c-bcb7-93f968dd82d612013-02-13
0904-0643-60EA - Each0904-0643a458cb98-2025-4d93-b87b-5c38bd11849c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
NITROGLYCERINACTIVE MOIETYG59M7S0WS3NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
ACETYLATED SUCROSE DISTEARATEINACTIVE INGREDIENTXLW9XG1719NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHNITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BNITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LNITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
SHELLACINACTIVE INGREDIENT46N107B71ONITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
NITROGLYCERINACTIVE MOIETYG59M7S0WS3NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
ACETYLATED SUCROSE DISTEARATEINACTIVE INGREDIENTXLW9XG1719NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHNITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LNITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BNITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SNITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LNITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
SHELLACINACTIVE INGREDIENT46N107B71ONITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
SUCROSEINACTIVE INGREDIENTC151H8M554NITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITRO-TIME (NITROGLYCERIN) CAPSULE [MAJOR PHARMACEUTICALS]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312013nitroglycerin 2.5 MG Extended Release Oral CapsulePSN93ee7bb4-4be0-45a4-8f5b-6b17c9f8cfdf2
312013nitroglycerin 2.5 MG Extended Release Oral CapsuleSCD93ee7bb4-4be0-45a4-8f5b-6b17c9f8cfdf2
312013NTG 2.5 MG Extended Release Oral CapsuleSY93ee7bb4-4be0-45a4-8f5b-6b17c9f8cfdf2
312013TNG 2.5 MG Extended Release Oral CapsuleSY93ee7bb4-4be0-45a4-8f5b-6b17c9f8cfdf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-0643-520090406435260 CAPSULE in 1 BOTTLE, PLASTIC (0904-0643-52) 60 capsule2004-01-292022-03-31NoNoCurrent