FDA.reportPublic FDA data

Nitroglycerin

Product NDC
43598-436
11-digit product format
435980436
Labeler code
43598
Product ID
43598-436_b6f146c9-be21-75da-dc27-e968a5f760ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Dr. Reddys Laboratories Inc
Application
ANDA208191
Marketing category
ANDA
Marketing start
2016-08-29
Substance
NITROGLYCERIN
Active strength
.4 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
Nitroglycerin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN.4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui198038, 198039, 198040

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
43598-436-01Nitroglycerin100 in 1 BOTTLETABLET1006
43598-436-11Nitroglycerin4 in 1 CARTONTABLET46
43598-436-35Nitroglycerin25 in 1 BOTTLETABLET256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-436-01EA - Each43598-4365a543a8e-c52d-4aa3-bbe4-bdf21409025712016-09-02
43598-436-11EA - Each43598-436daaf0e96-6b3e-40f8-9120-7457727d3ef912016-09-02
43598-436-35EA - Each43598-43662e71c52-beb4-4717-9eef-009a5b9554ae12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-436NITROGLYCERIN TABLET [DR. REDDYS LABORATORIES INC]5Current NDC, Legacy NDC, 3 package rows20170412_c555f8de-477f-0225-98a2-baf8945bbd63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198039nitroglycerin 0.4 MG Sublingual TabletPSNfc297c0a-a412-40be-8414-4bf9906fd30010
198039nitroglycerin 0.4 MG Sublingual TabletSCDfc297c0a-a412-40be-8414-4bf9906fd30010
198039nitroglycerin 400 MCG Sublingual TabletSYfc297c0a-a412-40be-8414-4bf9906fd30010
198039NTG 0.4 MG Sublingual TabletSYfc297c0a-a412-40be-8414-4bf9906fd30010
198039TNG 0.4 MG Sublingual TabletSYfc297c0a-a412-40be-8414-4bf9906fd30010
198038nitroglycerin 0.3 MG Sublingual TabletPSNc555f8de-477f-0225-98a2-baf8945bbd636
198039nitroglycerin 0.4 MG Sublingual TabletPSNc555f8de-477f-0225-98a2-baf8945bbd636
198039nitroglycerin 0.4 MG Sublingual TabletPSNc20e89b4-57b5-259d-e053-2a95a90a00386
198040nitroglycerin 0.6 MG Sublingual TabletPSNc555f8de-477f-0225-98a2-baf8945bbd636
198038nitroglycerin 0.3 MG Sublingual TabletSCDc555f8de-477f-0225-98a2-baf8945bbd636
198039nitroglycerin 0.4 MG Sublingual TabletSCDc555f8de-477f-0225-98a2-baf8945bbd636
198039nitroglycerin 0.4 MG Sublingual TabletSCDc20e89b4-57b5-259d-e053-2a95a90a00386
198040nitroglycerin 0.6 MG Sublingual TabletSCDc555f8de-477f-0225-98a2-baf8945bbd636
198038nitroglycerin 300 MCG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198039nitroglycerin 400 MCG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198039nitroglycerin 400 MCG Sublingual TabletSYc20e89b4-57b5-259d-e053-2a95a90a00386
198040nitroglycerin 600 MCG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198038NTG 0.3 MG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198039NTG 0.4 MG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198039NTG 0.4 MG Sublingual TabletSYc20e89b4-57b5-259d-e053-2a95a90a00386
198040NTG 0.6 MG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198038TNG 0.3 MG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198039TNG 0.4 MG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198039TNG 0.4 MG Sublingual TabletSYc20e89b4-57b5-259d-e053-2a95a90a00386
198040TNG 0.6 MG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198038nitroglycerin 0.3 MG Sublingual TabletPSNdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039nitroglycerin 0.4 MG Sublingual TabletPSNdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040nitroglycerin 0.6 MG Sublingual TabletPSNdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198038nitroglycerin 0.3 MG Sublingual TabletSCDdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039nitroglycerin 0.4 MG Sublingual TabletSCDdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040nitroglycerin 0.6 MG Sublingual TabletSCDdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198038nitroglycerin 300 MCG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039nitroglycerin 400 MCG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040nitroglycerin 600 MCG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198038NTG 0.3 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039NTG 0.4 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040NTG 0.6 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198038TNG 0.3 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039TNG 0.4 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040TNG 0.6 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039nitroglycerin 0.4 MG Sublingual TabletPSN67a15ee9-a6ae-4a60-8333-e06c608cfd714
198039nitroglycerin 0.4 MG Sublingual TabletSCD67a15ee9-a6ae-4a60-8333-e06c608cfd714
198039nitroglycerin 400 MCG Sublingual TabletSY67a15ee9-a6ae-4a60-8333-e06c608cfd714
198039NTG 0.4 MG Sublingual TabletSY67a15ee9-a6ae-4a60-8333-e06c608cfd714
198039TNG 0.4 MG Sublingual TabletSY67a15ee9-a6ae-4a60-8333-e06c608cfd714
198039nitroglycerin 0.4 MG Sublingual TabletPSN763ce792-c991-f472-e053-2a91aa0a77dd3
198039nitroglycerin 0.4 MG Sublingual TabletPSN6671d89f-cc89-c03c-e053-2a91aa0aa5fa3
198039nitroglycerin 0.4 MG Sublingual TabletSCD763ce792-c991-f472-e053-2a91aa0a77dd3
198039nitroglycerin 0.4 MG Sublingual TabletSCD6671d89f-cc89-c03c-e053-2a91aa0aa5fa3
198039nitroglycerin 400 MCG Sublingual TabletSY763ce792-c991-f472-e053-2a91aa0a77dd3
198039nitroglycerin 400 MCG Sublingual TabletSY6671d89f-cc89-c03c-e053-2a91aa0aa5fa3
198039NTG 0.4 MG Sublingual TabletSY6671d89f-cc89-c03c-e053-2a91aa0aa5fa3
198039NTG 0.4 MG Sublingual TabletSY763ce792-c991-f472-e053-2a91aa0a77dd3
198039TNG 0.4 MG Sublingual TabletSY763ce792-c991-f472-e053-2a91aa0a77dd3
198039TNG 0.4 MG Sublingual TabletSY6671d89f-cc89-c03c-e053-2a91aa0aa5fa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-436-0143598043601100 TABLET in 1 BOTTLE (43598-436-01) 100 tablet2016-08-290000-00-00NoNoCurrent
43598-436-11435980436114 BOTTLE in 1 CARTON (43598-436-11) / 25 TABLET in 1 BOTTLE (43598-436-35) 4 bottle2016-08-290000-00-00NoNoCurrent
43598-436-354359804363525 in 1 BOTTLEHistorical