NITROGLYCERIN

Product NDC
51662-1340
Requested package NDC
51662-1340-1
11-digit product format
516621340
Labeler code
51662
Product ID
51662-1340_ef6d3da2-6bf9-fbc7-e053-2a95a90a74cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROGLYCERIN
Dosage form
OINTMENT
Route
TOPICAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA087355
Marketing category
ANDA
Marketing start
2018-12-22
Substance
NITROGLYCERIN
Active strength
20 mg/g
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087355-001NITROGLYCERINNITROGLYCERIN2%OINTMENT / TRANSDERMALABRLD, RS1988-07-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A087355-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALABRLD, RS1988-07-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALABRLD, RS1988-07-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALABRLD, RS1988-07-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-083f01610625f2…
2019-09-15 20:21 UTC2019-09A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRLD, RS1988-07-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087355-001NITROGLYCERIN2%OINTMENT / TRANSDERMALRS1988-07-08cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A087355-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087355-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A087355-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A087355-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
NITROGLYCERIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN20 mg/g

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242946Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7da79fdf-0969-1ddd-e053-2991aa0a3ec4Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1340-1NITROGLYCERIN30 g in 1 TUBEOINTMENT304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1340NITROGLYCERIN OINTMENT [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Current NDC, Legacy NDC, 1 package rows20221211_7da79fdf-0969-1ddd-e053-2991aa0a3ec4.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITRO-BIDNITROGLYCERINSavage Laboratories a division of Fougera Pharmaceuticals, LLCe464e9bb-48e8-4b9f-9fff-e220cfbac0c52026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087355
application number: ANDA087355
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirst7da79fdf-0969-1ddd-e053-2991aa0a3ec42022-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087355
application number: ANDA087355
ndc (package): 51662-1340-1
ndc (product): 51662-1340
ndc11 (package): 51662134001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242946nitroglycerin 2 % Topical OintmentPSN7da79fdf-0969-1ddd-e053-2991aa0a3ec44
242946nitroglycerin 0.02 MG/MG Topical OintmentSCD7da79fdf-0969-1ddd-e053-2991aa0a3ec44
242946nitroglycerin 2 % Topical OintmentSY7da79fdf-0969-1ddd-e053-2991aa0a3ec44
242946NTG 0.02 MG/MG Topical OintmentSY7da79fdf-0969-1ddd-e053-2991aa0a3ec44
242946TNG 0.02 MG/MG Topical OintmentSY7da79fdf-0969-1ddd-e053-2991aa0a3ec44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1340-15166213400130 g in 1 TUBE (51662-1340-1) 30 g2018-12-220000-00-00NoNoCurrent