Nitroglycerin

Product NDC
60429-840
11-digit product format
604290840
Labeler code
60429
Product ID
60429-840_4b32b515-a550-088f-e063-6394a90a3ed0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA208191
Marketing category
ANDA
Marketing start
2016-08-26
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct60429-840EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage60429-84060429-840-04EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage60429-84060429-840-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208191-001NITROGLYCERINNITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26
A208191-002NITROGLYCERINNITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26
A208191-003NITROGLYCERINNITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A208191-001AB
A208191-002AB
A208191-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-261e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208191-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208191-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208191-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208191-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208191-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208191-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208191-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208191-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208191-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208191-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208191-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208191-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208191-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208191-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208191-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208191-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208191-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208191-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208191-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208191-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208191-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208191-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208191-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208191-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208191-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208191-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208191-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208191-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208191-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208191-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208191-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208191-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208191-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208191-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208191-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208191-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208191-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208191-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208191-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208191-001AB11e350fbaab3a…

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 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198038Internal RxNorm lookup
198039Internal RxNorm lookup
198040Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df52ab34-e44c-46f3-8c44-2c1bcb93f28eAvailable 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
60429-840-01Nitroglycerin100 in 1 BOTTLETABLET1005
60429-840-04Nitroglycerin4 in 1 CARTONTABLET45
60429-840-04Nitroglycerin25 in 1 BOTTLETABLET255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-840-01EA - Each60429-840819eb62c-d045-48c9-bfb4-95221a0cc3e312017-05-04
60429-840-04EA - Each60429-840e17c4f76-c1dd-4545-b31d-e44a3d6e458512017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-840NITROGLYCERIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]4Current NDC, Legacy NDC, 3 package rows20240726_df52ab34-e44c-46f3-8c44-2c1bcb93f28e.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitroglycerinNITROGLYCERINGolden State Medical Supply, Inc.df52ab34-e44c-46f3-8c44-2c1bcb93f28e2026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208191
application number: ANDA208191
ndc (product): 60429-840
NitroglycerinNITROGLYCERINDr. Reddys Laboratories Incc555f8de-477f-0225-98a2-baf8945bbd632026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208191
application number: ANDA208191
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirstc20e89b4-57b5-259d-e053-2a95a90a00382025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208191
application number: ANDA208191
NitroglycerinNITROGLYCERINA-S Medication Solutionsfc297c0a-a412-40be-8414-4bf9906fd3002023-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208191
application number: ANDA208191
NitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC6671d89f-cc89-c03c-e053-2a91aa0aa5fa2023-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208191
application number: ANDA208191
NitroglycerinNITROGLYCERINProficient Rx LP67a15ee9-a6ae-4a60-8333-e06c608cfd712022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208191
application number: ANDA208191

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-840-0160429084001100 TABLET in 1 BOTTLE (60429-840-01) 100 tablet2016-09-120000-00-00NoNoCurrent
60429-840-04604290840044 BOTTLE in 1 CARTON (60429-840-04) / 25 TABLET in 1 BOTTLE4 bottle2016-09-120000-00-00NoNoCurrent