Home NDC 50090-3894-0 PHENADOZ
Product NDC 50090-3894
Requested package NDC 50090-3894-0
11-digit product format 500903894
Labeler code 50090
Product ID 50090-3894_97ebeb4c-4d6c-4f8d-9e65-21e1906dede3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride
Dosage form SUPPOSITORY
Route RECTAL
Labeler A-S Medication Solutions
Application ANDA040428
Marketing category ANDA
Marketing start 2015-02-17
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 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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A040428-001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 A040428-002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 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 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3894 PHENADOZ (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [A-S MEDICATION SOLUTIONS] 8 Legacy NDC, 6 package rows 20210303_fd8cc8e0-edf1-4599-a7bc-2e924a8c859c.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 · 2 matching rows.
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 50090-3894-0 50090389400 12 PACKET in 1 BOX (50090-3894-0) > 1 SUPPOSITORY in 1 PACKET 12 packet 2018-12-04 0000-00-00 No No Current