FDA.reportPublic FDA data

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

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
0904-0647-52EA - Each0904-0647ede65180-8878-4ab3-bc32-e70316a2a13e12013-02-13
0904-0647-60EA - Each0904-0647251bdc3c-f3da-487c-a2c4-b3a890f6f5b612013-02-13

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
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNITRO-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 GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SNITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITRO-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
SUCROSEINACTIVE INGREDIENTC151H8M554NITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITRO-TIME (NITROGLYCERIN) CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312020nitroglycerin 9 MG Extended Release Oral CapsulePSNd308e2b0-9526-4efc-9566-a33717a87bcc4
312020nitroglycerin 9 MG Extended Release Oral CapsuleSCDd308e2b0-9526-4efc-9566-a33717a87bcc4
312020NTG 9 MG Extended Release Oral CapsuleSYd308e2b0-9526-4efc-9566-a33717a87bcc4
312020TNG 9 MG Extended Release Oral CapsuleSYd308e2b0-9526-4efc-9566-a33717a87bcc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-0647-520090406475260 CAPSULE in 1 BOTTLE, PLASTIC (0904-0647-52) 60 capsule2004-01-292022-12-31NoNoCurrent
0904-0647-6000904064760100 CAPSULE in 1 BOTTLE, PLASTIC (0904-0647-60) 100 capsule2004-01-292022-12-31NoNoCurrent