FDA.reportPublic FDA data

NITRO-TIME

Product NDC
49483-222
11-digit product format
494830222
Labeler code
49483
Product ID
49483-222_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
6.5 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
NITROGLYCERIN6.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui312013, 312018, 312020

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
49483-222-06NITRO-TIME60 in 1 BOTTLE, PLASTICCAPSULE608
49483-222-10NITRO-TIME100 in 1 BOTTLE, PLASTICCAPSULE1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-222-06EA - Each49483-22204074bd7-530b-4650-9e3f-f85865195b0f12013-02-13
49483-222-10EA - Each49483-222018214ee-3316-4f11-9bcf-ba2009fa21c512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-222NITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]4Current NDC, Legacy NDC, 2 package rows20181010_3c11c1c2-8e62-4f63-8293-2f8b8d845f7e.zip

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
49483-222-064948302220660 CAPSULE in 1 BOTTLE, PLASTIC (49483-222-06) 60 capsule2018-10-090000-00-00NoNoCurrent
49483-222-1049483022210100 CAPSULE in 1 BOTTLE, PLASTIC (49483-222-10) 100 capsule2018-10-090000-00-00NoNoCurrent