NDC 0641-6099-01 - 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
- 0641-6099
- Requested NDC
- 0641-6099-01
- Package NDCs from labels
- 0641-6099-01, 0641-6099-25
- Manufacturer
- West-ward Pharmaceutical Corp. | West-ward Pharmaceutical Corp
- Effective date
- 2011-09-15
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| PROMETHAZINE - West-ward Pharmaceutical Corp. | West-ward Pharmaceutical Corp | West-ward Pharmaceutical Corp. | West-ward Pharmaceutical Corp | 2011-09-15 | 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0641-6099-25 | 2024-06-05 | C162847 | 48780-1 | 960f7f55-d58f-8e05-e053-dbdaa90a074a | Promethazine Hydrochloride Injection, USP Rx only |
| 0641-6099-25 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d58f-8e05-e053-dbdaa90a074a | Promethazine Hydrochloride Injection, USP Rx only |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6099-01 | ML - Milliliter | 0641-6099 | 44485d47-ac32-4783-97cd-c5cb391cca8d | 1 | 2012-07-24 |
| 0641-6099-25 | ML - Milliliter | 0641-6099 | c055dafe-ee66-446f-963b-9f3d22150d8a | 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 |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | Hikma Pharmaceuticals USA Inc. | 78ef7ad3-451d-43d0-a9b6-5cf0aadca003 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | b0d5abba-6fae-4f3c-b990-dd9c83c7b5a9 | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | ANDA083312 R61ZEH7I1I |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 365138a6-28d8-4881-a3e9-02c80aaf83e8 | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | ANDA083312 R61ZEH7I1I |
| Sterile Water | WATER | B. Braun Medical Inc. | 8fc8d87a-3951-4ac5-97df-c161ffc90475 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | da246971-20b8-b46e-8366-9700d3604cf1 | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Eye Wash | WATER | M-star (Hubei) Health&Care Products Co., Ltd. | 71706039-e250-4f08-9687-71b2928c4e46 | 2024-04-01 | Warnings | 059QF0KO0R |
| Sore Throat Cherry | PHENOL | Family Dollar (FAMILY WELLNESS) | 7806fac7-736e-44b0-baa2-42feb7237417 | 2024-03-27 | Warnings | 339NCG44TV |
| ACETIC ACID | ACETIC ACID | Chartwell RX, LLC | 2aaf3781-4f25-4799-8dcd-78d67e226ccc | 2024-03-26 | Warnings, Adverse reactions | Q40Q9N063P |
| Calcium Chloride | CALCIUM CHLORIDE | American Regent, Inc. | c5ef90b3-6ef0-410c-97d7-66a130b90741 | 2024-03-26 | Warnings, Adverse reactions | M4I0D6VV5M |
| ULINE Eyewash | EYEWASH | Uline. | 14545fc9-1fb4-befa-e063-6294a90a0474 | 2024-03-23 | Warnings | 059QF0KO0R |
| Balanced Salt | SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE | B. Braun Medical Inc. | 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 | 2024-03-13 | Warnings, Adverse reactions | M4I0D6VV5M 4550K0SC9B |
| Chemtox | BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOL | Deseret Biologicals, Inc. | 91f52c95-f36d-4754-8570-f81ed8d36180 | 2024-03-06 | Warnings | 339NCG44TV |
| Calcium Chloride | CALCIUM CHLORIDE | International Medication Systems, Limited | 8295039b-2559-4626-90c8-6ac7e896e41a | 2024-03-01 | Warnings, Adverse reactions | M4I0D6VV5M |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Asclemed USA, Inc. | b4985d9d-1aa0-4b36-bc98-6a5410ad9bad | 2024-02-26 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| CALCIUM CHLORIDE | CALCIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a9500f41-8041-d753-e053-2a95a90a6f3c | 2024-02-26 | Warnings, Adverse reactions | M4I0D6VV5M |
| PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | 744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a | 2024-02-22 | Boxed warning, Warnings, Adverse reactions | ANDA083312 R61ZEH7I1I |
| PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | 7447e8c6-c198-cd2d-e053-2a91aa0a3895 | 2024-02-22 | Boxed warning, Warnings, Adverse reactions | ANDA083312 R61ZEH7I1I |
| GI Drainage | CINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOS | Deseret Biologicals, Inc. | ff81e3ca-2f88-4daf-a734-083107269d3a | 2024-02-21 | Warnings | 059QF0KO0R |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | e451cb8d-f856-479f-bee9-4cccab210b1e | 2024-02-12 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Dysbio Plus | ACETICUM ACIDUM, ALOE, ARSENICUM ALBUM, BOTULINUM, BRUGIA MALAYI, CHININUM SULPHURICUM, CHOLERA NOSODE, CLOSTRIDIUM DIFFICILE, COLCHICUM AUTUMNALE, COLIBACILLINUM CUM NATRUM MURIATICUM, COLOCYNTHIS, ECHINACEA (ANGUSTIFOLIA), HELICOBACTER PYLORI, HELICOBACTER PYLORI DNA, MERCURIUS CORROSIVUS, MORGAN GAERTNER, NUX VOMICA, PROTEUS (VULGARIS), SALMONELLA TYPHI NOSODE | Deseret Biologicals, Inc. | 6864ab8e-3cf9-460e-b471-84ba3fb2efe0 | 2024-02-07 | Warnings | Q40Q9N063P |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.