FDA.reportPublic FDA data

Application 040027

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDESYRUP;ORAL15MG/5ML;6.25MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040027-001PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE15MG/5ML;6.25MG/5MLSYRUP / ORAL1996-07-31

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A040027-001PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE15MG/5ML;6.25MG/5MLSYRUP / ORAL1996-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040027-001PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE15MG/5ML;6.25MG/5MLSYRUP / ORAL1996-07-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040027-001PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE15MG/5ML;6.25MG/5MLSYRUP / ORAL1996-07-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040027-001PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE15MG/5ML;6.25MG/5MLSYRUP / ORAL1996-07-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040027-001AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A040027-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040027-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040027-001AA1ea99ee380514…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAdvagen Pharma Ltd8b60eff2-5759-4bc3-ac16-5ff80aa153a02026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDECamber Pharmaceuticals, Inc.6a2cd2d6-6e0f-4b2d-be7a-8b99627f44532026-06-09Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAtlantic Biologicals Corp.5022379d-05ef-63f2-e063-6294a90a21892026-04-23Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack709519cb-d124-4469-b329-b67e1bba214b2026-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDECranbury Pharmaceuticals, LLCa8b57027-a4b8-4149-93e8-aa3e7a6d6dc32025-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDECosette Pharmaceuticals, Inc.e7b336d9-b1df-4a08-9b67-754346d365f42025-09-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutions87f9e9fb-5433-478b-9f23-e16883a9d2a92025-09-23Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEANI Pharmaceuticals, Inc.a52e210f-b99d-493e-b679-ec565c6ff72d2025-08-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAsclemed USA, Inc.702eb7c0-db4c-4729-b69e-99f64c63c7bd2025-05-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEXttrium Laboratories, Inc30c9d769-bc74-04d2-e063-6294a90a665a2025-04-07Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAmneal Pharmaceuticals LLC6081c216-0bed-40f0-8732-f999647003d52024-10-30Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionse451cb8d-f856-479f-bee9-4cccab210b1e2024-02-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsee227c52-2cd8-4a06-a2de-a257f1f4732a2023-07-11Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50383-803Promethazine Hydrochloride and Dextromethophan HydrobromidePromethazine Hydrochloride and Dextromethophan HydrobromideAkornANDACurrent
50383-803Promethazine Hydrochloride and Dextromethophan HydrobromidePromethazine Hydrochloride and Dextromethophan HydrobromideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-803Promethazine Hydrochloride and Dextromethophan HydrobromidePromethazine Hydrochloride and Dextromethophan HydrobromideHi-Tech Pharmacal Co., Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42565ORIG2003-07-30