Home NDC 28595-120-49 NITROGLYCERIN LINGUAL
Product NDC 28595-120
Requested package NDC 28595-120-49
11-digit product format 285950120
Labeler code 28595
Product ID 28595-120_462b36d0-0a1e-bda8-e063-6294a90a5792
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitroglycerin
Dosage form SPRAY
Route ORAL
Labeler Allegis Pharmaceuticals, LLC
Application NDA018705
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2019-07-01
Marketing end 2027-01-31
Substance NITROGLYCERIN
Active strength 400 ug/1
Pharmacologic classes Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag No
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018705-001 NITROLINGUAL NITROGLYCERIN 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 N018705-002 NITROLINGUAL PUMPSPRAY NITROGLYCERIN 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018705-002 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11
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 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base NITROGLYCERIN LINGUAL Active Ingredients# Ingredient, Strength table Ingredient Strength NITROGLYCERIN 400 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G59M7S0WS3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 705129 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 28595-120-12 NITROGLYCERIN LINGUAL 1 in 1 CARTON SPRAY 1 3 28595-120-12 NITROGLYCERIN LINGUAL 200 in 1 BOTTLE SPRAY 200 3 28595-120-49 NITROGLYCERIN LINGUAL 1 in 1 CARTON SPRAY 1 3 28595-120-49 NITROGLYCERIN LINGUAL 60 in 1 BOTTLE SPRAY 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 28595-120 NITROGLYCERIN LINGUAL (NITROGLYCERIN) SPRAY [ALLEGIS PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 4 package rows 20230202_fadd07b7-189b-4678-ad0f-bf1e4d3d1300.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NITROGLYCERIN LINGUAL NITROGLYCERIN Allegis Pharmaceuticals, LLC fadd07b7-189b-4678-ad0f-bf1e4d3d1300 2025-12-17 Warnings, Adverse reactions Exact identifier application applno (NDA): 018705 application number: NDA018705 ndc (package): 28595-120-49 ndc (product): 28595-120 ndc11 (package): 28595012049 NITROGLYCERIN NITROGLYCERIN HF Acquisition Co LLC, DBA HealthFirst 422b4713-9531-f1bf-e063-6294a90ada2b 2025-10-27 Warnings, Adverse reactions Exact identifier application applno (NDA): 018705 application number: NDA018705 NITROLINGUAL NITROGLYCERIN INDEPENDENCE PHARMACEUTICALS, LLC d19b5f51-ca85-48d6-9ccd-8ae26249cdc3 2024-05-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 018705 application number: NDA018705 NITROGLYCERIN LINGUAL NITROGLYCERIN LINGUAL HF Acquisition Co LLC, DBA HealthFirst a8eb91f6-7f2e-7d57-e053-2995a90a3893 2024-02-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 018705 application number: NDA018705 Nitroglycerin NITROGLYCERIN Prasco Laboratories f9731c86-34b0-42a2-8b39-eca907e02e74 2024-01-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 018705 application number: NDA018705
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 28595-120-49 28595012049 1 BOTTLE in 1 CARTON (28595-120-49) / 60 SPRAY in 1 BOTTLE 1 bottle 2019-07-01 2027-01-31 No No Current