| Drug NDC: | 48951-1347 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. | |
| Proprietary Name: | Aquavit |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. | |
| Non Proprietary Name: | Aquavit |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Uriel Pharmacy Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. | |
| Substance Name: | AMBERGRIS - 11 [hp_X]/mL ANGELICA ARCHANGELICA ROOT - 2 [hp_X]/mL ANISE - 2 [hp_X]/mL BLACK PEPPER - 2 [hp_X]/mL CALENDULA OFFICINALIS FLOWERING TOP - 2 [hp_X]/mL CARAWAY SEED - 2 [hp_X]/mL CARDAMOM - 2 [hp_X]/mL CENTAURIUM ERYTHRAEA FLOWERING TOP - 2 [hp_X]/mL CHAMOMILE - 2 [hp_X]/mL CINNAMON - 2 [hp_X]/mL Load more... COLA NITIDA SEED - 2 [hp_X]/mL CORIANDER OIL - 2 [hp_X]/mL EQUISETUM ARVENSE TOP - 2 [hp_X]/mL FENNEL SEED - 2 [hp_X]/mL FERRIC OXIDE RED - 9 [hp_X]/mL FERROUS ARSENATE - 6 [hp_X]/mL FUMARIA OFFICINALIS FLOWERING TOP - 2 [hp_X]/mL GINGER - 2 [hp_X]/mL GOLD - 10 [hp_X]/mL HONEY - 2 [hp_X]/mL HYSSOPUS OFFICINALIS WHOLE - 2 [hp_X]/mL IMPERATORIA OSTRUTHIA ROOT - 2 [hp_X]/mL JUNIPER BERRY - 2 [hp_X]/mL LAVANDULA ANGUSTIFOLIA FLOWER - 2 [hp_X]/mL LESSER GALANGAL ROOT - 2 [hp_X]/mL LITSEA CUBEBA FRUIT - 2 [hp_X]/mL LONG PEPPER - 2 [hp_X]/mL MYRISTICA FRAGRANS WHOLE - 2 [hp_X]/mL NUTMEG - 2 [hp_X]/mL OREGANO - 2 [hp_X]/mL PRUNUS SPINOSA FLOWER BUD - 9 [hp_X]/mL QUILLAJA SAPONARIA BARK - 2 [hp_X]/mL ROSMARINUS OFFICINALIS FLOWERING TOP - 2 [hp_X]/mL SAFFRON - 2 [hp_X]/mL SEDUM ROSEUM WHOLE - 2 [hp_X]/mL ST. JOHN'S WORT - 2 [hp_X]/mL SWEET MARJORAM - 2 [hp_X]/mL SYZYGIUM AROMATICUM FRUIT - 2 [hp_X]/mL TANGERINE - 2 [hp_X]/mL THYME - 2 [hp_X]/mL VANILLA BEAN - 2 [hp_X]/mL WHITE PEPPER - 2 [hp_X]/mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | ORAL |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Marketing Start Date: | 01 Sep, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 23 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. | |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Uriel Pharmacy Inc. |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. | |
| Original Packager: | Yes |
| Whether or not the drug has been repackaged for distribution. | |
| NUI: | N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0008672 M0022575 M0516536 N0000185508 N0000185015 N0000185001 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | XTC0D02P6C DTN01M69SN 21C2F5E8RE KM66971LVF 18E7415PXQ W2FH8O2BBE 8BC4CUT4JL ZL25KMM82T FGL3685T2X 5S29HWU6QB Load more... PQM9SA369U 7626GC95E5 1DP6Y6B65Z G3QC02NIE6 1K09F3G675 129CO35H12 VH659J61ZL C5529G5JPQ 79Y1949PYO Y9H1V576FH 0IQW001KPE G0NV8P17X0 O84B5194RL 19AH1RAF4M 42LD90786Y R3617MQA5Z 2NMG4EA7B1 MF7T8BM40A AEE24M3MQ9 0E5AT8T16U 53Y84VPS2W 8N0K3807ZW 8JM482TI79 E849G4X5YJ RH0WP583U3 UFH8805FKA G9Z40ZYU6P 0P6ERS26LL KH3E3096OO CW657OBU4N Q74T35078H M29DW54Q9E |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. | |
| Pharmacologic Class EPC: | Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Standardized Chemical Allergen [EPC] |
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. | |
| Pharmacologic Class PE: | Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [PE] |
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. | |
| Pharmacologic Class CS: | Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Food Additives [CS] Vegetable Proteins [CS] Seed Storage Proteins [CS] |
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. | |
| Pharmacologic Class: | Allergens [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Food Additives [CS] Fruit Proteins [EXT] Increased Histamine Release [PE] Increased IgG Production [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Seed Storage Proteins [CS] Standardized Chemical Allergen [EPC] Vegetable Proteins [CS] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 48951-1347-3 | 60 mL in 1 BOTTLE, DROPPER (48951-1347-3) | 01 Sep, 2009 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. | ||||
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