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 |
|---|---|---|---|---|---|---|
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | c0c0d4f0-8396-485b-a585-71df01491f6f | 2023-11-07 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | b96904e7-cc67-4abc-b946-8423f3f897ff | 2023-10-24 | Warnings, Adverse reactions | R61ZEH7I1I |
| HPYL PLUS | ANGELICA ARCHANGELICA, GERANIUM MACULATUM, HYDRASTIS CANADENSIS, SINAPIS NIGRA, SYMPHYTUM OFFICINALE, RATANHIA, ACETICUM ACIDUM, CARBOLICUM ACIDUM, ORNITHOGALUM UMBELLATUM, ABIES CANADENSIS, ANACARDIUM ORIENTALE, BISMUTHUM SUBNITRICUM, CONDURANGO, GRAPHITES, IRIS VERSICOLOR, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MEZEREUM, EUPHORBIUM OFFICINARUM, NUX VOMICA | Deseret Biologicals, Inc. | c90278bf-b08a-4c79-86c0-dafd3b7756c6 | 2023-10-12 | Warnings | Q40Q9N063P 339NCG44TV |
| Sore throat cherry | PHENOL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | de634cf1-ed39-4d8a-8855-006c69b7aee9 | 2023-10-10 | Warnings | 339NCG44TV |
| Isolyte S pH 7.4 | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE | B. Braun Medical Inc. | 150437b6-320e-4c69-a434-2a26a1f0b2e4 | 2023-10-06 | Warnings, Adverse reactions | 4550K0SC9B |
| BHI Migraine | ACETIC ACID, ARANEUS DIADEMATUS, ASAFETIDA, BRYONIA ALBA WHOLE, TRIBASIC CALCIUM PHOSPHATE, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, MARSDENIA CONDURANGO BARK, TUBOCURARINE CHLORIDE, KALMIA LATIFOLIA LEAF, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, PHOSPHORIC ACID, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, AND SILICON DIOXIDE | MediNatura Inc | 11cad8ba-6914-420e-bab0-4ca37d33f2e6 | 2023-09-28 | Warnings | Q40Q9N063P |
| Physiolyte | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | B. Braun Medical Inc. | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 2023-09-26 | Warnings, Adverse reactions | 4550K0SC9B |
| Pancreas Sarcode | CHAMOMILLA, GLYCYRRHIZA GLABRA, SYZYGIUM JAMBOLANUM, VACCINIUM MYRTILLUS, ACETICUM ACIDUM, CONDURANGO, PHASEOLUS, SARSAPARILLA (SMILAX REGELII), PANCREAS SUIS, URICUM ACIDUM | Nutritional Specialties, Inc. | 56a6dbc1-3a6b-444f-8082-1999a64e529c | 2023-09-25 | Warnings | Q40Q9N063P |
| promethazine hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | c0a68671-407b-4840-9662-04f168cff1cb | 2023-09-10 | Boxed warning, Warnings, Adverse reactions | R61ZEH7I1I |
| Natrum Aceticum | NATRUM ACETICUM | Hahnemann Laboratories, INC. | 04cdea6c-8348-d855-e063-6294a90a6660 | 2023-09-07 | 4550K0SC9B | |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | B. Braun Medical Inc. | a9910e09-5aea-4ee1-a35e-ae4abf8b80b4 | 2023-09-07 | Warnings, Adverse reactions | M4I0D6VV5M |
| ANUBISMED | HA HYALURONIC | ANUBIS COSMETICS SL | eac771e2-4c1b-3808-e053-2995a90ac5fc | 2023-09-05 | Warnings | 059QF0KO0R |
| AnubisMed | SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION | ANUBIS COSMETICS SL | e99d92c4-8768-9c0a-e053-2a95a90a609e | 2023-09-05 | Warnings | 059QF0KO0R |
| AnubisMed | AZELAIC ACID, SALICYLIC ACID | ANUBIS COSMETICS SL | ebf3153d-30f5-54e4-e053-2995a90a74b1 | 2023-09-05 | Warnings | 059QF0KO0R |
| AnubisMed | GLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACID | ANUBIS COSMETICS SL | eca95dde-cb57-2ab6-e053-2995a90af84f | 2023-09-05 | Warnings | 059QF0KO0R |
| AnubisMed | SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA | ANUBIS COSMETICS SL | ebf4b3ab-34e1-185a-e053-2a95a90ace3a | 2023-09-05 | Warnings | 059QF0KO0R |
| Lipotox | SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, | BioActive Nutritional, Inc. | a1538692-ca00-4e52-9b7e-409767ee27e1 | 2023-09-05 | Warnings | Q40Q9N063P |
| Anubis Barcelona | GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE | ANUBIS COSMETICS SL | eb651769-4d98-2b3b-e053-2a95a90a36b0 | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona | DMAE | ANUBIS COSMETICS SL | f22b212d-d21d-5984-e053-2995a90a683e | 2023-09-01 | Warnings | 059QF0KO0R |
| Anubis Barcelona | DMAE, ZIRHAFIRM | ANUBIS COSMETICS SL | f2274f8c-08aa-eb02-e053-2a95a90a3998 | 2023-09-01 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.