NDC 49999-090-05 - 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
- 49999-090
- Requested NDC
- 49999-090-05
- Package NDCs from labels
- 49999-090-05
- Manufacturer
- Lake Erie Medical DBA Quality Care Products LLC | Watson Pharma Private Limited
- Effective date
- 2010-11-24
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Promethazine Hydrochloride 25 mg | Lake Erie Medical DBA Quality Care Products LLC | Watson Pharma Private Limited | 2010-11-24 | 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49999-090-05 | EA - Each | 49999-090 | bb61fd6f-ca97-4920-949c-f6ab76edb72b | 1 | 2012-07-24 |
| 49999-090-10 | EA - Each | 49999-090 | ed6993b0-c7c5-43d0-bff6-a14fdfd6de7f | 1 | 2012-07-24 |
| 49999-090-12 | EA - Each | 49999-090 | 7bd36e6f-97eb-48c7-9c42-04087c5ecd4f | 1 | 2012-07-24 |
| 49999-090-15 | EA - Each | 49999-090 | e465e7e7-1297-4e7f-9cb2-0322ba2644ee | 1 | 2012-07-24 |
| 49999-090-20 | EA - Each | 49999-090 | 959a5d8e-e5af-4d1e-832f-69a4fc4c5bd1 | 1 | 2012-07-24 |
| 49999-090-30 | EA - Each | 49999-090 | 5ad8cb71-ffba-435d-a6d0-78588b28cf08 | 1 | 2012-07-24 |
| 49999-090-60 | EA - Each | 49999-090 | be8efc83-1115-4539-92e2-08d9611f9005 | 1 | 2012-07-24 |
| 49999-090-90 | EA - Each | 49999-090 | 5cf09f61-35f1-4076-bbd1-b81834de94c8 | 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 and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Asclemed USA, Inc. | 702eb7c0-db4c-4729-b69e-99f64c63c7bd | 2025-05-07 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Xttrium Laboratories, Inc. | 302bfea2-d403-d315-e063-6294a90a37dd | 2025-04-07 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Xttrium Laboratories, Inc | 30c9d769-bc74-04d2-e063-6294a90a665a | 2025-04-07 | Warnings, Adverse reactions | R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Kesin Pharma Corporation | 28793bd2-bd40-4571-e063-6394a90ae789 | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| YVTYVT MICRODERMABRASION FACIAL SCRUB | YVTYVT MICRODERMABRASION FACIAL SCRUB | Beijing JUNGE Technology Co., Ltd. | 2f30fc45-42e2-c766-e063-6394a90a8d68 | 2025-02-28 | Warnings | OP1R32D61U |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 74834e1b-0d90-0542-e053-2991aa0aa1ef | 2025-02-10 | Warnings, Adverse reactions | ANDA083426 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Coupler LLC | 2d996287-9eed-265a-e063-6294a90a6969 | 2025-02-07 | Boxed warning, Warnings, Adverse reactions | 992475 R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION | NuCare Pharmaceuticals,Inc. | 0b7bfbab-decb-970c-e063-6394a90a50ef | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 12400c65-f93b-47a5-8167-1fb14337130b | 2025-01-07 | Warnings, Adverse reactions | 992475 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f4c23037-e415-7604-e053-2995a90a5bb6 | 2024-12-31 | Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Zydus Lifesciences Limited | 4eaa8291-9cde-4205-857b-925ea8d618ba | 2024-12-04 | 992475 992447 R61ZEH7I1I | |
| Promethazine Hydrochloride and Phenylephrine Hydrochloride | PROMETHAZINE AND PHENYLEPHRINE | Amneal Pharmaceuticals LLC | cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4 | 2024-10-30 | Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Amneal Pharmaceuticals LLC | 6081c216-0bed-40f0-8732-f999647003d5 | 2024-10-30 | Warnings, Adverse reactions | R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 05907a49-537f-4bf2-8a5f-5e905f19fece | 2024-10-30 | Warnings, Adverse reactions | 992475 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 6aa6bfcc-024b-4ee2-a586-6c4ca879cea4 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 69eea039-0098-4e2f-a832-152583b16f05 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | b7137912-d119-4899-9c93-09c1c625f290 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 84899861-8fed-536d-e053-2991aa0a42b2 | 2024-09-26 | Boxed warning, Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | a4fbc2d8-19b3-4556-b0b9-6e7a14cd4c36 | 2024-09-13 | Boxed warning, Warnings, Adverse reactions | 992447 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 07914b6e-c40f-44be-a1db-8724c70f99b6 | 2024-08-15 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.