Cefotan (Page 6 of 6)
HOW SUPPLIED
CEFOTAN® (cefotetan for Injection, USP) is a dry, white to pale yellow powder supplied in vials containing cefotetan disodium equivalent to 1 g and 2 g cefotetan activity for intravenous and intramuscular administration. The vials should be stored at 20⁰C to 25⁰ C (68⁰ to 77⁰ F) [see USP Controlled Room Temperature] and should be protected from light.
The following packages are available:
| NDC No. | Strength | |
| 52565-052-10 | 1 gram | 10 mL vial, packaged in a tray of 10 |
| 52565-053-10 | 2 grams | 20 mL vial, packaged in a tray of 10 |
Vial stoppers do not contain natural rubber latex.
‡Clinitest® is a registered trademark of Ames Division, Miles Laboratories, Inc.
CEFOTAN® is a registered trademark of Teligent Pharma, Inc.
Manufactured for:
Teligent Pharma, Inc.
Buena, NJ 08310
Made in Italy
Revised: November 2018
PACKAGE LABEL. CARTON PRINCIPAL DISPLAY PANEL, 1 Gram Carton
NDC 52565-052-10
Cefotan®
(Cefotetan For Injection)
Equivalent to 1 gram Cefotetan per vial
10 x 10mL Vials
Protect from Light
Must be reconstituted.
For intravenous infusion or intramuscular injection.
PACKAGE LABEL. CARTON PRINCIPAL DISPLAY PANEL, 2 Gram Carton
NDC 52565-053-10
Cefotan®
(Cefotetan For Injection)
Equivalent to 2 grams Cefotetan per vial
10 — 20 mL Vials
Protect from Light
KEEP TOP CLOSED
Must be reconstituted.
For intravenous infusion or intramuscular injection.
| CEFOTAN cefotetan disodium injection, powder, for solution | |||||||||||||||||
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| CEFOTAN cefotetan disodium injection, powder, for solution | |||||||||||||||||
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| Labeler — Teligent Pharma, Inc. (011036910) |
| Registrant — Teligent Pharma, Inc. (011036910) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| ACSDobfar S.p.A | 439962157 | api manufacture (52565-052), api manufacture (52565-053) | |
Revised: 11/2018 Teligent Pharma, Inc.
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