Home NDC 42291-648-90 Nitroglycerin
Product NDC 42291-648
Requested package NDC 42291-648-90
11-digit product format 422910648
Labeler code 42291
Product ID 42291-648_ba4d45db-b713-1fe5-e053-2995a90abf56
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitroglycerin
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2012-12-19
Marketing end 0000-00-00
Substance NITROGLYCERIN
Active strength 3 mg/1
Pharmacologic classes Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nitroglycerin ACTIVE INGREDIENT G59M7S0WS3 NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 Nitroglycerin ACTIVE MOIETY G59M7S0WS3 NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 D&c Red No. 22 INACTIVE INGREDIENT 1678RKX8RT NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 D&c Red No. 28 INACTIVE INGREDIENT 767IP0Y5NH NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 D&c Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 Ethylcelluloses INACTIVE INGREDIENT 7Z8S9VYZ4B NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 Fd&c Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 Fd&c Red No. 40 INACTIVE INGREDIENT WZB9127XOA NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 Fd&c Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 Gelatin INACTIVE INGREDIENT 2G86QN327L NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 Shellac INACTIVE INGREDIENT 46N107B71O NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 Sucrose INACTIVE INGREDIENT C151H8M554 NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1 Talc INACTIVE INGREDIENT 7SEV7J4R1U NITROGLYCERIN ER (NITROGLYCERIN) CAPSULE [AVKARE, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-648-90 42291064890 90 CAPSULE in 1 BOTTLE (42291-648-90) 90 capsule 2012-12-19 0000-00-00 No No Current