FDA.reportPublic FDA data

Oxytetracycline Dihydrate

Manufacturer
Norbrook Laboratories Limited
Effective date
2017-05-15
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
1
Source
full-release
Hydrated at
2026-06-01 02:49:34

Label at a glance#

ProductOxytetracycline Dihydrate
Active ingredientOxytetracycline
Label structure1 sections

Label contents#

Full prescribing information#

Principal Display Panel - Drum Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OXYTETRACYCLINE

DIHYDRATE USP

Warning

CAS No. 6153-64-6

EC No. 201-212-8

Store below 25°C, protected from light.

Caution: For manufacturing, processing, or repacking
Caution: Federal (U.S.A.) law restricts this drug to use by or
on the order of a licensed veterinarian

NET WEIGHT: RESOURCE CODE:

BATCH NUMBER: DATE OF MANUFACTURE:

DRUM NUMBER: DATE OF EXPIRY:

Norbrook® Laboratories Limited

Newry, Co Down, BT35 6QQ

Northern Ireland

Tel: +44 (0)28 3026 4435

Fax: +44 (0)28 3026 5060

Email: enquiries@norbrook.co.uk

www.norbrook.com

Norbrook®

Principal Display Panel - Drum Label
Principal Display Panel - Drum Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYTETRACYCLINE ANHYDROUS Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55529-650-32Oxytetracycline Dihydrate10 kg in 1 DRUMPOWDER101
55529-650-33Oxytetracycline Dihydrate25 kg in 1 DRUMPOWDER251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55529-650OXYTETRACYCLINE DIHYDRATE (OXYTETRACYCLINE) POWDER [NORBROOK LABORATORIES LIMITED]12 package rows20200401_e9ee0117-08b4-45d4-9f39-aaeb3594278e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55529-65055529-650-32, 55529-650-33

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
OxytetracyclineX20I9EN955ACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.