NDC 68382-0041 - Promethazine hydrochloride
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68382-0041
- Manufacturer
- State of Florida DOH Central Pharmacy
- Effective date
- 2010-06-01
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Promethazine hydrochloride - State of Florida DOH Central Pharmacy | State of Florida DOH Central Pharmacy | 2010-06-01 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 46b869e2-9305-43ae-bb15-919a6d09b6ff | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Chartwell Governmental & Specialty RX, LLC. | e5d2156d-1f66-4fdf-a3ae-5e1325218c8b | 2025-11-21 | Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | American Health Packaging | a8fe4bc5-961b-4441-b8e2-ef93e4e137b6 | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | ANDA040596 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | American Health Packaging | 57b4bf23-c563-4357-9dcf-066cbc1280e4 | 2025-11-13 | Warnings, Adverse reactions | ANDA040596 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | d7675718-0a57-41ff-a771-79afc12150aa | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | c525cb2c-9a01-4a9b-ad2c-08630719953d | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | e16238dc-9292-49ac-b80f-8afeccb88bc5 | 2025-10-24 | Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| PROMETHEGAN | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97 | 2025-10-20 | Boxed warning, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7d766cf7-a21c-4eaf-bbdc-00f2939ef19a | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Cosette Pharmaceuticals, Inc. | e7b336d9-b1df-4a08-9b67-754346d365f4 | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | 87f9e9fb-5433-478b-9f23-e16883a9d2a9 | 2025-09-23 | Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Major Pharmaceuticals | 4cee8622-7d59-4794-8e32-54f7aac1d923 | 2025-09-22 | Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | BluePoint Laboratories | 44cd6d46-fbb9-4836-9426-d8ce2cb6d66d | 2025-09-12 | Boxed warning, Warnings, Adverse reactions | ANDA040596 992447 R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | ANI Pharmaceuticals, Inc. | a52e210f-b99d-493e-b679-ec565c6ff72d | 2025-08-08 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 7a186bcd-ab8c-4695-8289-4cd33bb551cf | 2025-08-05 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Schuessler Tissue Salts Calc Phos Bone Health 2 | CALCAREA PHOSPHORICA | Martin & Pleasance Pty Ltd | c277f1d8-2ee0-4111-adb6-38998f77dede | 2025-07-18 | Warnings | L11K75P92J |
| Schuessler Tissue Salts Calc Phos Bone Health 2 | CALCAREA PHOSPHORICA | Martin & Pleasance Pty Ltd | 81d59754-1b36-4f71-aec1-5335b003a96f | 2025-07-01 | Warnings | L11K75P92J |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 13d9e59d-eadb-41d5-9f47-9c11a6efb31c | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | d545105f-27dc-4820-b0b1-fcf17e0be0f0 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| PHENERGAN | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 6f7e47cc-f823-4336-8107-f980e3049617 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.