FDA.reportPublic FDA data

Rectiv

Product NDC
58914-301
11-digit product format
589140301
Labeler code
58914
Product ID
58914-301_a2f0ef5a-c3b6-4330-9b33-131369431ddd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
OINTMENT
Route
RECTAL
Labeler
Allergan, Inc.
Application
NDA021359
Marketing category
NDA
Marketing start
2011-06-21
Marketing end
2027-02-28
Substance
NITROGLYCERIN
Active strength
4 mg/g
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rectiv

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN4 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui1114466, 1114470

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
58914-301-80Rectiv30 g in 1 TUBEOINTMENT3015
58914-301-80Rectiv1 in 1 CARTONOINTMENT115
58914-301-85Rectiv5 g in 1 TUBEOINTMENT515
58914-301-85Rectiv1 in 1 CARTONOINTMENT115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58914-301-80GM - Gram58914-30174f754c7-2846-465e-87b7-6f78d67589ef12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3RECTIV (NITROGLYCERIN) OINTMENT [APTALIS PHARMA US, INC.]3
NITROGLYCERINACTIVE MOIETYG59M7S0WS3RECTIV (NITROGLYCERIN) OINTMENT [APTALIS PHARMA US, INC.]3
LANOLININACTIVE INGREDIENT7EV65EAW6HRECTIV (NITROGLYCERIN) OINTMENT [APTALIS PHARMA US, INC.]3
PARAFFININACTIVE INGREDIENTI9O0E3H2ZERECTIV (NITROGLYCERIN) OINTMENT [APTALIS PHARMA US, INC.]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9URECTIV (NITROGLYCERIN) OINTMENT [APTALIS PHARMA US, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RECTIV (NITROGLYCERIN) OINTMENT [APTALIS PHARMA US, INC.]3
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ARECTIV (NITROGLYCERIN) OINTMENT [APTALIS PHARMA US, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58914-301RECTIV (NITROGLYCERIN) OINTMENT [ALLERGAN, INC.]14Current NDC, Legacy NDC, 4 package rows20240727_603aa9ed-54c4-4a35-ade4-690fa44850e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114466nitroglycerin 0.4 % Rectal OintmentPSN603aa9ed-54c4-4a35-ade4-690fa44850e415
1114470RECTIV 0.4 % Rectal OintmentPSN603aa9ed-54c4-4a35-ade4-690fa44850e415
1114470nitroglycerin 0.004 MG/MG Rectal Ointment [Rectiv]SBD603aa9ed-54c4-4a35-ade4-690fa44850e415
1114466nitroglycerin 0.004 MG/MG Rectal OintmentSCD603aa9ed-54c4-4a35-ade4-690fa44850e415
1114466nitroglycerin 0.4 % Rectal OintmentSY603aa9ed-54c4-4a35-ade4-690fa44850e415
1114466NTG 0.004 MG/MG Rectal OintmentSY603aa9ed-54c4-4a35-ade4-690fa44850e415
1114470NTG 0.004 MG/MG Rectal Ointment [Rectiv]SY603aa9ed-54c4-4a35-ade4-690fa44850e415
1114470Rectiv 0.004 MG/MG Rectal OintmentSY603aa9ed-54c4-4a35-ade4-690fa44850e415
1114470Rectiv 0.4 % Topical OintmentSY603aa9ed-54c4-4a35-ade4-690fa44850e415
1114466TNG 0.004 MG/MG Rectal OintmentSY603aa9ed-54c4-4a35-ade4-690fa44850e415
1114470TNG 0.004 MG/MG Rectal Ointment [Rectiv]SY603aa9ed-54c4-4a35-ade4-690fa44850e415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58914-301-80589140301801 TUBE in 1 CARTON (58914-301-80) / 30 g in 1 TUBE1 tube2011-06-212027-02-28NoNoCurrent
58914-301-85589140301851 TUBE in 1 CARTON (58914-301-85) > 5 g in 1 TUBE1 tube2011-06-210000-00-00NoNoCurrent