FDA Orange Book
Generic for Nebcin
Nebcin contains tobramycin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Nebcin is tobramycin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Nebcin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 1.2GM BASE/VIAL | Discontinued | None | 5 | AP |
| injectable, injection | EQ 10MG BASE/ML | Discontinued | None | 2 | AP |
NDA 050519, 050477, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tobramycin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| XGEN PHARMACEUTICALS DJB INC | 065013 | AP (A-rated, therapeutically equivalent) | August 17, 2001 | EQ 1.2GM BASE/VIAL |
| FRESENIUS KABI USA LLC | 065122 | AP (A-rated, therapeutically equivalent) | November 29, 2002 | EQ 10MG BASE/ML |
| XELLIA PHARMACEUTICALS APS | 205685 | AP (A-rated, therapeutically equivalent) | September 16, 2014 | EQ 1.2GM BASE/VIAL |
| GLAND PHARMA LTD | 209621 | AP (A-rated, therapeutically equivalent) | February 11, 2021 | EQ 10MG BASE/ML |
| GLAND PHARMA LTD | 211189 | AP (A-rated, therapeutically equivalent) | May 18, 2021 | EQ 1.2GM BASE/VIAL |
| HAINAN POLY PHARM CO LTD | 217029 | AP (A-rated, therapeutically equivalent) | February 1, 2023 | EQ 1.2GM BASE/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 217519 | AP (A-rated, therapeutically equivalent) | June 21, 2023 | EQ 1.2GM BASE/VIAL |
Questions
Is there a generic for Nebcin?
Yes. The generic name for Nebcin is tobramycin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Nebcin?
The active ingredient in Nebcin is tobramycin, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.