Home NDC 50090-1618 Promethazine Hydrochloride
Product NDC 50090-1618
11-digit product format 500901618
Labeler code 50090
Product ID 50090-1618_654e53c6-dd2f-4a72-a36e-3c237fca48b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA040622
Marketing category ANDA
Marketing start 2006-07-18
Marketing end 0000-00-00
Substance PROMETHAZINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2019-12-31
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 2 · 117 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-1618-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-1618-6 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-1618-9 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-1618-5 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-1618-0 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-1618-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-1618-6 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-1618-9 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-1618-5 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-1618-0 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-1618-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-1618-6 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-1618-9 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-1618-5 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-1618-0 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-1618-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-1618-6 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-1618-9 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-1618-5 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-1618-0 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-1618-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-1618-6 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-1618-9 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-1618-5 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-1618-0 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-1618-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-1618-6 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-1618-9 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-1618-5 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-1618-0 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-1618-1 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-1618-6 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-1618-9 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-1618-5 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-1618-0 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-1618-1 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-1618-6 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-1618-9 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-1618-5 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-1618-0 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-1618-1 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-1618-6 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-1618-9 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-1618-5 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-1618-0 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-1618-1 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-1618-6 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-1618-9 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-1618-5 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-1618-0 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040622-001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 A040622-002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 A040622-003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 129 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 2026-09-14 22:38:34 2026-08 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040622-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040622-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040622-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040622-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040622-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040622-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040622-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040622-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040622-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040622-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040622-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040622-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040622-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040622-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040622-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040622-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040622-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040622-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040622-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040622-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040622-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040622-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040622-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040622-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040622-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2006-07-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040622-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2006-07-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040622-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2006-07-18 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 50090-1618-0 Promethazine Hydrochloride 12 in 1 BOTTLE TABLET 12 5 50090-1618-1 Promethazine Hydrochloride 10 in 1 BOTTLE TABLET 10 5 50090-1618-5 Promethazine Hydrochloride 60 in 1 BOTTLE TABLET 60 5 50090-1618-6 Promethazine Hydrochloride 20 in 1 BOTTLE TABLET 20 5 50090-1618-9 Promethazine Hydrochloride 30 in 1 BOTTLE TABLET 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1618 PROMETHAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] 5 Legacy NDC, 5 package rows 20180115_3aa0033d-a6f8-44bf-9280-e8565bd05eb7.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 50090-1618-0 50090161800 12 in 1 BOTTLE Historical 50090-1618-1 50090161801 10 in 1 BOTTLE Historical 50090-1618-5 50090161805 60 in 1 BOTTLE Historical 50090-1618-6 50090161806 20 in 1 BOTTLE Historical 50090-1618-9 50090161809 30 in 1 BOTTLE Historical