NDC 54575-401
HALIBUT
Pacific Halibut
HALIBUT is a Percutaneous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Allergy Laboratories, Inc.. The primary component is Pacific Halibut.
| Product ID | 54575-401_dbe7bebd-e445-4e59-8302-e706b795fbde |
| NDC | 54575-401 |
| Product Type | Human Prescription Drug |
| Proprietary Name | HALIBUT |
| Generic Name | Pacific Halibut |
| Dosage Form | Injection, Solution |
| Route of Administration | PERCUTANEOUS; SUBCUTANEOUS |
| Marketing Start Date | 1972-08-29 |
| Marketing Category | BLA / BLA |
| Application Number | BLA102192 |
| Labeler Name | Allergy Laboratories, Inc. |
| Substance Name | PACIFIC HALIBUT |
| Active Ingredient Strength | 1 g/20mL |
| Pharm Classes | Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
Packaging
NDC 54575-401-10
10 mL in 1 VIAL, MULTI-DOSE (54575-401-10)
| Marketing Start Date | 1972-08-29 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 54575-401-50 [54575040150]
HALIBUT INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2020-01-31 |
NDC 54575-401-02 [54575040102]
HALIBUT INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2020-01-31 |
NDC 54575-401-10 [54575040110]
HALIBUT INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2020-01-31 |
NDC 54575-401-30 [54575040130]
HALIBUT INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PACIFIC HALIBUT | 1 g/20mL |
OpenFDA Data
Pharmacological Class
- Non-Standardized Food Allergenic Extract [EPC]
- Increased Histamine Release [PE]
- Cell-mediated Immunity [PE]
- Allergens [CS]
- Dietary Proteins [CS]
- Fish Proteins
- Dietary [EXT]
NDC Crossover Matching brand name "HALIBUT" or generic name "Pacific Halibut"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0268-6236 | HALIBUT | ATLANTIC HALIBUT |
| 0268-7130 | HALIBUT | HIPPOGLOSSUS HIPPOGLOSSUS |
| 36987-1218 | Halibut | Halibut |
| 36987-1219 | Halibut | Halibut |
| 36987-1220 | Halibut | Halibut |
| 36987-1221 | Halibut | Halibut |
| 49288-0251 | Halibut | Halibut |
| 49288-0252 | Halibut | Halibut |
| 54575-401 | HALIBUT | pacific halibut |
Trademark Results [HALIBUT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HALIBUT 88861382 not registered Live/Pending |
Koch OÃ 2020-04-06 |
 HALIBUT 78686563 not registered Dead/Abandoned |
Laboratorios Andromaco Lda 2005-08-05 |
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