NDC 0641-1496-31 - 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
- 0641-1496
- Requested NDC
- 0641-1496-31
- Package NDCs from labels
- 0641-1496-31, 0641-1496-35
- Manufacturer
- Henry Schein, Inc.
- Effective date
- 2026-10-12
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Promethazine HCL 50 mg/mL Injection, USP 1 mL Single Dose Ampule | Henry Schein, Inc. | 2026-10-12 | 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 HCI - HF Acquisition Co. LLC, DBA HealthFirst | HF Acquisition Co. LLC, DBA HealthFirst | 2024-02-22 | HUMAN PRESCRIPTION DRUG LABEL |
| Promethazine Hydrochloride - General Injectables & Vaccines, Inc | General Injectables & Vaccines, Inc | 2022-12-29 | HUMAN PRESCRIPTION DRUG LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2012-07-24 | Indexing - Billing Unit |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-1496-31 | Promethazine Hydrochloride | 1 mL in 1 AMPULE | INJECTION | 1 | 5 | |
| 0641-1496-35 | Promethazine Hydrochloride | 25 in 1 PACKAGE | INJECTION | 25 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-1496-31 | ML - Milliliter | 0641-1496 | c081beed-7064-44b2-ae3e-5b0344536968 | 1 | 2012-07-24 |
| 0641-1496-35 | ML - Milliliter | 0641-1496 | 356a6fa1-501c-4099-b031-6f5581d18a22 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | American Health Packaging | a8fe4bc5-961b-4441-b8e2-ef93e4e137b6 | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | American Health Packaging | 57b4bf23-c563-4357-9dcf-066cbc1280e4 | 2025-11-13 | Warnings, Adverse reactions | R61ZEH7I1I |
| Eyesaline Eyewash Concentrate | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 3765c251-eb14-d60f-e063-6294a90a6a4d | 2025-11-12 | Warnings | 059QF0KO0R |
| Eyesaline Emergency Eyewash | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 37f244fd-c02f-e66a-e063-6394a90aed81 | 2025-11-12 | Warnings | 059QF0KO0R |
| TopCare Cherry Flavor | PHENOL | TOPCO ASSOCIATES, LLC | 5d3f0610-deb4-4180-ae19-2c65ed2f368b | 2025-11-10 | Warnings | 339NCG44TV |
| Topcare Sore Throat Menthol Flavor | PHENOL | TOPCO ASSOCIATES LLC | fb1f2c11-2508-4985-bae5-7d547bd6aa23 | 2025-11-10 | Warnings | 339NCG44TV |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | d7675718-0a57-41ff-a771-79afc12150aa | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | ANDA083312 992460 R61ZEH7I1I |
| STERILE WATER | WATER | Henry Schein, Inc. | f4087143-9868-4308-b96c-43657ee8ec28 | 2025-11-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | c525cb2c-9a01-4a9b-ad2c-08630719953d | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | ANDA083312 0404-9942-01 0404-9942 992858 b4183b6c-f338-4914-a618-75cb78c0bb7e c525cb2c-9a01-4a9b-ad2c-08630719953d R61ZEH7I1I |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | B. Braun Medical Inc. | d3d29c8f-c326-4097-814a-7f4e08c67068 | 2025-11-05 | Warnings, Adverse reactions | M4I0D6VV5M |
| Ringers | SODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDE | B. Braun Medical Inc. | 01721071-af03-4894-95c1-10b8bc64b888 | 2025-11-05 | Warnings, Adverse reactions | M4I0D6VV5M |
| Dextrose in Lactated Ringers | DEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | B. Braun Medical Inc. | 190da07e-a616-46e6-b4e5-1c0ba39306e5 | 2025-11-05 | Warnings, Adverse reactions | M4I0D6VV5M |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | B. Braun Medical Inc. | f6d82772-638c-4584-b9d3-8833669f5963 | 2025-11-05 | Warnings, Adverse reactions | M4I0D6VV5M |
| Bacteriostatic Water | BACTERIOSTATIC WATER | ProPharma Distribution | 42c6938e-f747-ae13-e063-6294a90a59a3 | 2025-11-04 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | ICU Medical Inc. | aab10f03-26ae-4dbc-a481-ef025e48b405 | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | ICU Medical Inc. | e3484bc6-ed7f-43ef-9d49-c131a8dff2dd | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Lactated Ringers and Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE | ICU Medical Inc. | d310d170-5eeb-471b-af1a-0e845001d21d | 2025-11-02 | Warnings, Adverse reactions | M4I0D6VV5M |
| Potassium Chloride in Lactated Ringers and Dextrose | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE | ICU Medical Inc. | 237b39fa-916e-4a54-99c8-4ae9ad54f056 | 2025-10-30 | Warnings, Adverse reactions | M4I0D6VV5M |
| Castellani Paint | PHENOL | Stratus Pharamceuticals | 74192c0e-3c73-4ab0-96d1-1917cbd6777a | 2025-10-30 | Warnings | 339NCG44TV |
| SKIN TAG REMOVER | SALICYLIC ACID | Shenzhen Yaozhihong Technology Co., Ltd. | 4246d4d5-9955-ba5a-e063-6394a90a8448 | 2025-10-29 | Warnings | Q40Q9N063P |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.