Home NDC 51672-5296 Promethazine Hydrochloride
Product NDC 51672-5296
11-digit product format 516725296
Labeler code 51672
Product ID 51672-5296_03f5c25b-a1d6-496d-8231-4100c5bcdbe4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride
Dosage form SUPPOSITORY
Route RECTAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA040428
Marketing category ANDA
Marketing start 2015-06-01
Marketing end 0000-00-00
Substance PROMETHAZINE HYDROCHLORIDE
Active strength 13 mg/1
Pharmacologic classes Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2020-12-31
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, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 51672-5296 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51672-5296 51672-5296-1 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product 51672-5296 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51672-5296 51672-5296-1 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 51672-5296 I Inactivated by FDA excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51672-5296 51672-5296-1 I Inactivated by FDA excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product 51672-5296 I Inactivated by FDA excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51672-5296 51672-5296-1 I Inactivated by FDA excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product 51672-5296 I Inactivated by FDA excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51672-5296 51672-5296-1 I Inactivated by FDA excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product 51672-5296 I Inactivated by FDA excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51672-5296 51672-5296-1 I Inactivated by FDA excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 51672-5296 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51672-5296 51672-5296-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 51672-5296 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51672-5296 51672-5296-1 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 51672-5296 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51672-5296 51672-5296-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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.
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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-5296-1 Promethazine Hydrochloride 12 in 1 CARTON SUPPOSITORY 12 3 51672-5296-1 Promethazine Hydrochloride 1 in 1 BLISTER PACK SUPPOSITORY 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Promethazine Hydrochloride ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] 1 Promethazine ACTIVE MOIETY FF28EJQ494 PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] 1 ascorbyl palmitate INACTIVE INGREDIENT QN83US2B0N PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] 1 fat, hard INACTIVE INGREDIENT 8334LX7S21 PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] 1 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] 1 white wax INACTIVE INGREDIENT 7G1J5DA97F PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-5296 PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.] 3 Legacy NDC, 2 package rows 20191220_1240d030-9856-4a92-976a-d443507c743a.zip
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 51672-5296-1 51672529601 12 BLISTER PACK in 1 CARTON (51672-5296-1) > 1 SUPPOSITORY in 1 BLISTER PACK 12 blister pack 2015-06-01 0000-00-00 No No Current