nitroglycerin lingual

Product NDC
45802-210
11-digit product format
458020210
Labeler code
45802
Product ID
45802-210_e75425f2-a532-4b73-9b24-258a7dcc34b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
SPRAY
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA091496
Marketing category
ANDA
Marketing start
2013-09-20
Substance
NITROGLYCERIN
Active strength
400 ug/1
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
A091496-001NITROGLYCERINNITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091496-001AB

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 UTC2026-02A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-203f01610625f2…
2019-09-15 20:21 UTC2019-09A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091496-001NITROGLYCERIN0.4MG/SPRAYSPRAY, METERED / SUBLINGUALAB2013-09-20cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091496-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091496-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091496-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091496-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091496-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091496-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091496-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091496-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091496-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091496-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091496-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091496-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091496-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091496-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091496-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091496-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091496-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091496-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091496-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091496-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091496-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091496-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091496-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091496-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091496-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091496-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091496-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091496-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091496-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091496-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091496-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091496-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091496-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091496-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091496-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091496-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091496-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091496-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091496-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091496-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN400 ug/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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
705129Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e7bbeff1-e4f1-43a6-a1b3-a8c3dcae817dAvailable 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
45802-210-01nitroglycerin lingual1 in 1 CARTONSPRAY18
45802-210-01nitroglycerin lingual60 in 1 BOTTLESPRAY608
45802-210-02nitroglycerin lingual1 in 1 CARTONSPRAY18
45802-210-02nitroglycerin lingual200 in 1 BOTTLESPRAY2008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-210-01GM - Gram45802-210cab59bf7-7a7d-4f2e-8353-d44e0b5ffbdb12013-10-17
45802-210-02GM - Gram45802-210feebf190-6c0f-4213-b3fa-c5e4aeca611312013-10-17

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-210NITROGLYCERIN LINGUAL (NITROGLYCERIN) SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD]8Current NDC, Legacy NDC, 4 package rows20231025_e7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROGLYCERIN LINGUALNITROGLYCERIN LINGUALHF Acquisition Co LLC, DBA HealthFirst947e4e68-ef8a-6c63-e053-2a95a90ac1932025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091496
application number: ANDA091496
NITROGLYCERIN LINGUALNITROGLYCERIN LINGUALHF Acquisition Co LLC, DBA HealthFirst9483ea48-0b1e-68c0-e053-2995a90a84d52025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091496
application number: ANDA091496
nitroglycerin lingualNITROGLYCERINPadagis Israel Pharmaceuticals Ltde7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d2022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091496
application number: ANDA091496
ndc (product): 45802-210

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705129nitroglycerin 400 MCG/ACTUAT Mucosal SprayPSNe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129nitroglycerin 0.4 MG/ACTUAT Mucosal SpraySCDe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129nitroglycerin 400 MCG/ACTUAT Mucosal SpraySYe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129nitroglycerin 400 MCG/ACTUAT Oral SpraySYe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129nitroglycerin 400 MCG/ACTUAT Sublingual SpraySYe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129NTG 0.4 MG/ACTUAT Mucosal SpraySYe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129TNG 0.4 MG/ACTUAT Mucosal SpraySYe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129nitroglycerin 400 MCG/ACTUAT Mucosal SprayPSN947e4e68-ef8a-6c63-e053-2a95a90ac1933
705129nitroglycerin 400 MCG/ACTUAT Mucosal SprayPSN9483ea48-0b1e-68c0-e053-2995a90a84d53
705129nitroglycerin 0.4 MG/ACTUAT Mucosal SpraySCD947e4e68-ef8a-6c63-e053-2a95a90ac1933
705129nitroglycerin 0.4 MG/ACTUAT Mucosal SpraySCD9483ea48-0b1e-68c0-e053-2995a90a84d53
705129nitroglycerin 400 MCG/ACTUAT Mucosal SpraySY947e4e68-ef8a-6c63-e053-2a95a90ac1933
705129nitroglycerin 400 MCG/ACTUAT Mucosal SpraySY9483ea48-0b1e-68c0-e053-2995a90a84d53
705129nitroglycerin 400 MCG/ACTUAT Oral SpraySY947e4e68-ef8a-6c63-e053-2a95a90ac1933
705129nitroglycerin 400 MCG/ACTUAT Oral SpraySY9483ea48-0b1e-68c0-e053-2995a90a84d53
705129nitroglycerin 400 MCG/ACTUAT Sublingual SpraySY9483ea48-0b1e-68c0-e053-2995a90a84d53
705129nitroglycerin 400 MCG/ACTUAT Sublingual SpraySY947e4e68-ef8a-6c63-e053-2a95a90ac1933
705129NTG 0.4 MG/ACTUAT Mucosal SpraySY9483ea48-0b1e-68c0-e053-2995a90a84d53
705129NTG 0.4 MG/ACTUAT Mucosal SpraySY947e4e68-ef8a-6c63-e053-2a95a90ac1933
705129TNG 0.4 MG/ACTUAT Mucosal SpraySY9483ea48-0b1e-68c0-e053-2995a90a84d53
705129TNG 0.4 MG/ACTUAT Mucosal SpraySY947e4e68-ef8a-6c63-e053-2a95a90ac1933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-210-01458020210011 BOTTLE in 1 CARTON (45802-210-01) / 60 SPRAY in 1 BOTTLE1 bottle2013-09-200000-00-00NoNoCurrent
45802-210-02458020210021 BOTTLE in 1 CARTON (45802-210-02) / 200 SPRAY in 1 BOTTLE1 bottle2013-09-200000-00-00NoNoCurrent