Home NDC 35356-815-30 Hydromorphone Hydrochloride
Product NDC 35356-815
Requested package NDC 35356-815-30
11-digit product format 353560815
Labeler code 35356
Product ID 35356-815_21554c87-8e58-410a-9f31-3200a5b91d28
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydromorphone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA078439
Marketing category ANDA
Marketing start 2009-12-09
Marketing end 0000-00-00
Substance HYDROMORPHONE HYDROCHLORIDE
Active strength 4 mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2021-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog .
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 35356-815-01 2025-01-14 HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg 35356-815-30 2025-01-14 HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg 35356-815-60 2025-01-14 HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg 35356-815-90 2025-01-14 HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg 35356-815-01 2022-01-28 HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg 35356-815-30 2022-01-28 HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg 35356-815-60 2022-01-28 HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg 35356-815-90 2022-01-28 HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 35356-815-30 35356081530 30 TABLET in 1 BOTTLE, PLASTIC (35356-815-30) 30 tablet 2009-12-09 0000-00-00 No No Current