NDC 36987-1349
Orange
Orange
Orange is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nelco Laboratories, Inc.. The primary component is Orange.
| Product ID | 36987-1349_255e0c54-6613-460b-a91f-452fdfd0319d |
| NDC | 36987-1349 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Orange |
| Generic Name | Orange |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRADERMAL; SUBCUTANEOUS |
| Marketing Start Date | 1972-08-29 |
| Marketing Category | BLA / BLA |
| Application Number | BLA102192 |
| Labeler Name | Nelco Laboratories, Inc. |
| Substance Name | ORANGE |
| Active Ingredient Strength | 0 g/mL |
| Pharm Classes | Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 36987-1349-4
50 mL in 1 VIAL, MULTI-DOSE (36987-1349-4)
| Marketing Start Date | 1972-08-29 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 36987-1349-1 [36987134901]
Orange INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
NDC 36987-1349-4 [36987134904]
Orange INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
NDC 36987-1349-3 [36987134903]
Orange INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
NDC 36987-1349-2 [36987134902]
Orange INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ORANGE | .1 g/mL |
OpenFDA Data
Pharmacological Class
- Non-Standardized Food Allergenic Extract [EPC]
- Increased Histamine Release [PE]
- Cell-mediated Immunity [PE]
- Allergens [CS]
- Dietary Proteins [CS]
- Fruit Proteins [EXT]
NDC Crossover Matching brand name "Orange" or generic name "Orange"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0268-6187 | ORANGE | ORANGE |
| 22840-5736 | Orange | Citrus X sinensis |
| 36987-1346 | Orange | Orange |
| 36987-1347 | Orange | Orange |
| 36987-1348 | Orange | Orange |
| 36987-1349 | Orange | Orange |
| 49288-0333 | Orange | Orange |
| 54575-423 | ORANGE FOOD | orange |
Trademark Results [Orange]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.