NDC 0641-1495-31 - 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
- 0641-1495
- Requested NDC
- 0641-1495-31
- Package NDCs from labels
- 0641-1495-31, 0641-1495-35
- Manufacturer
- Henry Schein, Inc.
- Effective date
- 2025-11-07
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Promethazine HCL 25 mg/mL Injection, USP 1 mL Single Dose Ampule | Henry Schein, Inc. | 2025-11-07 | HUMAN PRESCRIPTION DRUG LABEL |
| Promethazine Hydrochloride Injection, USP | Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A | 2025-06-30 | HUMAN PRESCRIPTION DRUG LABEL |
| Promethazine Hydrochloride Injection, USP | REMEDYREPACK INC. | 2023-10-03 | HUMAN PRESCRIPTION DRUG LABEL |
| Promethazine Hydrochloride - Medical Purchasing Solutions, LLC | Medical Purchasing Solutions, LLC | 2023-05-02 | HUMAN PRESCRIPTION DRUG LABEL |
| Promethazine Hydrochloride - General Injectables & Vaccines, Inc | General Injectables & Vaccines, Inc | 2022-12-29 | HUMAN PRESCRIPTION DRUG LABEL |
| Model AA-8565CV-ACT Model AA-8565CV - Aerospace Accessory Service, Inc | Aerospace Accessory Service, Inc | 2021-05-18 | MEDICAL DEVICE |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2012-07-24 | Indexing - Billing Unit |
| Promethazine Hydrochloride Injection, USP Rx only | Dispensing Solutions Inc. | 2010-03-02 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-1495-31 | Promethazine Hydrochloride | 1 mL in 1 AMPULE | INJECTION | 1 | 5 | |
| 0641-1495-35 | Promethazine Hydrochloride | 25 in 1 CARTON | INJECTION | 25 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-1495-31 | ML - Milliliter | 0641-1495 | 8f71d813-efd2-4f08-b2fa-1b5da840c091 | 1 | 2012-07-24 |
| 0641-1495-35 | ML - Milliliter | 0641-1495 | 4630f281-0707-4994-872a-ee7bd8a6722d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.