NITRO-TIME

Product NDC
49483-221
11-digit product format
494830221
Labeler code
49483
Product ID
49483-221_51ed5c69-89ac-27ed-e063-6394a90acca1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROGLYCERIN
Dosage form
CAPSULE
Route
ORAL
Labeler
TIME CAP LABORATORIES, INC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-06-19
Substance
NITROGLYCERIN
Active strength
2.5 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NITRO-TIME
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G59M7S0WS3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312013Internal RxNorm lookup
312018Internal RxNorm lookup
312020Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c11c1c2-8e62-4f63-8293-2f8b8d845f7eAvailable on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-221-06NITRO-TIME60 in 1 BOTTLE, PLASTICCAPSULE608
49483-221-10NITRO-TIME100 in 1 BOTTLE, PLASTICCAPSULE1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-221-06EA - Each49483-22152711070-d6f7-456e-b5d4-aa59117776a812013-02-13
49483-221-10EA - Each49483-221da0017b8-5837-4037-afd8-b31f623fee2112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NitroglycerinACTIVE INGREDIENTG59M7S0WS3NITROGLYCERIN ER (NITROGLYCERIN ) CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
NitroglycerinACTIVE MOIETYG59M7S0WS3NITROGLYCERIN ER (NITROGLYCERIN ) CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
NITROGLYCERINACTIVE MOIETYG59M7S0WS3NITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHNITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LNITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BNITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SNITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
GELATININACTIVE INGREDIENT2G86QN327LNITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
SHELLACINACTIVE INGREDIENT46N107B71ONITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
SUCROSEINACTIVE INGREDIENTC151H8M554NITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FNITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]2
NitroglycerinACTIVE INGREDIENTG59M7S0WS3NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
NitroglycerinACTIVE MOIETYG59M7S0WS3NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
D&c Red No. 22INACTIVE INGREDIENT1678RKX8RTNITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
D&c Red No. 28INACTIVE INGREDIENT767IP0Y5NHNITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GNITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
EthylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BNITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
Fd&c Blue No. 1INACTIVE INGREDIENTH3R47K3TBDNITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
Fd&c Red No. 40INACTIVE INGREDIENTWZB9127XOANITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
GelatinINACTIVE INGREDIENT2G86QN327LNITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XNITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
ShellacINACTIVE INGREDIENT46N107B71ONITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJNITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
SucroseINACTIVE INGREDIENTC151H8M554NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1
TalcINACTIVE INGREDIENT7SEV7J4R1UNITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-221NITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]4Current NDC, Legacy NDC, 2 package rows20181010_3c11c1c2-8e62-4f63-8293-2f8b8d845f7e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITRO-TIMENITROGLYCERINTIME CAP LABORATORIES, INC3c11c1c2-8e62-4f63-8293-2f8b8d845f7e2026-05-18Warnings, Adverse reactionsExact identifier
ndc (product): 49483-221

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312013nitroglycerin 2.5 MG Extended Release Oral CapsulePSN3c11c1c2-8e62-4f63-8293-2f8b8d845f7e8
312018nitroglycerin 6.5 MG Extended Release Oral CapsulePSN3c11c1c2-8e62-4f63-8293-2f8b8d845f7e8
312020nitroglycerin 9 MG Extended Release Oral CapsulePSN3c11c1c2-8e62-4f63-8293-2f8b8d845f7e8
312013nitroglycerin 2.5 MG Extended Release Oral CapsuleSCD3c11c1c2-8e62-4f63-8293-2f8b8d845f7e8
312018nitroglycerin 6.5 MG Extended Release Oral CapsuleSCD3c11c1c2-8e62-4f63-8293-2f8b8d845f7e8
312020nitroglycerin 9 MG Extended Release Oral CapsuleSCD3c11c1c2-8e62-4f63-8293-2f8b8d845f7e8
312013NTG 2.5 MG Extended Release Oral CapsuleSY3c11c1c2-8e62-4f63-8293-2f8b8d845f7e8
312018NTG 6.5 MG Extended Release Oral CapsuleSY3c11c1c2-8e62-4f63-8293-2f8b8d845f7e8
312020NTG 9 MG Extended Release Oral CapsuleSY3c11c1c2-8e62-4f63-8293-2f8b8d845f7e8
312013TNG 2.5 MG Extended Release Oral CapsuleSY3c11c1c2-8e62-4f63-8293-2f8b8d845f7e8
312018TNG 6.5 MG Extended Release Oral CapsuleSY3c11c1c2-8e62-4f63-8293-2f8b8d845f7e8
312020TNG 9 MG Extended Release Oral CapsuleSY3c11c1c2-8e62-4f63-8293-2f8b8d845f7e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-221-064948302210660 CAPSULE in 1 BOTTLE, PLASTIC (49483-221-06) 60 capsule2018-10-090000-00-00NoNoCurrent
49483-221-1049483022110100 CAPSULE in 1 BOTTLE, PLASTIC (49483-221-10) 100 capsule2018-10-090000-00-00NoNoCurrent