FDA.reportPublic FDA data

AMPROLIUM - Phibro Animal Health Ltd. | Phibro Animal Health

Manufacturer
Phibro Animal Health Ltd. | Phibro Animal Health
Effective date
2026-08-03
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
10
Source
daily-update
Hydrated at
2026-08-06 06:10:36

Label at a glance#

ProductAMPROLIUM
Active ingredientAMPROLIUM
Label structure7 sections

Storage and handling

Keep container tightly closed in a dry and well-ventilated place. Store in accordance with local regulations. Keep/store only in original container. Store between 5°C and 25°C, excursion permitted up to 40°C.

Label contents#

Full prescribing information#

Package Label/Prinicipal Display Panel

SPL UNCLASSIFIED SECTION

For the manufacture of veterinary pharmaceutical products only.
1-[(4-Amino-2-Propyl-5-Pyrimidinyl) Methyl]-2-Methylpyridinium Chloride Hydrochloride

WARNINGS AND PRECAUTIONS SECTION

Note: Keep container tightly closed.
Note: For additional information, see Material Safety Data Sheets for this material.

FIRST AID MEASURES

USER SAFETY WARNINGS SECTION


Eye contact: Rinse thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids.
Consult a physician.
Inhalation: Remove to fresh air.
Skin contact: Wash off immediately with soap and plenty of water while removing all contaminated
clothes and shoes.
Ingestion: Consult a physician if necessary.
Self-protection of the first aider: use personal protective equipment as required.

STORAGE CONDITIONS

STORAGE AND HANDLING SECTION

Keep container tightly closed in a dry and well-ventilated place.
Store in accordance with local regulations. Keep/store only in original container.
Store between 5°C and 25°C, excursion permitted up to 40°C.

SPL UNCLASSIFIED SECTION

Lot:

Manuf. Date:

Retest Date:

Net Weight 25kg

SPL UNCLASSIFIED SECTION

Product license holder:
Phibro Animal Health Corporation, Glenpointe Centre East,
3rd FL
300 Frank W. Burr Blvd, Ste 21,
Teaneck, NJ 07666
United states of America


Manufacturing site:
Phibro Animal Health Corporation
601 Beam St, Salisbury, Maryland 21801
United States of America


FEI Number: 1150033
NDC# 54277-0022-1

101-8305-01

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54277-0022-12022-01-28C16284748780-1d6a99b39-981d-a426-e053-dadaa90af4c2AMPROLIUM
54277-0022-12022-01-28C16284748780-1d6a99b39-981d-a426-e053-dadaa90af4c2AMPROLIUM
54277-0022-12022-01-28C16284748780-1d6a99b39-981d-a426-e053-dadaa90af4c2AMPROLIUM

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54277-002254277-0022-1

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
AMPROLIUM95CO6N199QACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92026-04-02full-release2026-06-01 02:52:44
82026-03-25monthly-update2026-06-03 17:59:07

Reported adverse events (FAERS/openFDA)#

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