Home NDC 51662-1351 NITROGLYCERIN
Product NDC 51662-1351
11-digit product format 516621351
Labeler code 51662
Product ID 51662-1351_ef7bda2f-c978-0108-e053-2995a90acb4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NITROGLYCERIN
Dosage form SPRAY
Route ORAL
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application NDA018705
Marketing category NDA
Marketing start 2018-11-27
Marketing end 0000-00-00
Substance NITROGLYCERIN
Active strength 400 ug/1
Pharmacologic classes Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51662-1351-9 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51662-1351-9 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 84 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 2026-08-18 06:07:40 2026-07 N018705-001 NITROLINGUAL 0.4MG/SPRAY AEROSOL / SUBLINGUAL 1985-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018705-002 NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB RLD, RS 1997-01-10 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N018705-002 7872049 2029-03-12 U-2223 Drug product 2012-04-11 caaa826d4ba7…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…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51662-1351-9 NITROGLYCERIN 60 in 1 BOTTLE SPRAY 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1351 NITROGLYCERIN SPRAY [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 4 Legacy NDC, 1 package rows 20221211_7b9f526c-6682-e675-e053-2991aa0a4b1e.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 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 51662-1351-9 51662135109 60 SPRAY in 1 BOTTLE (51662-1351-9) 60 spray 2018-11-27 0000-00-00 No No Current