Compudose

Manufacturer
Elanco US Inc.
Effective date
2025-10-28
Label type
OTC ANIMAL DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:46:14

Label at a glance#

ProductCompudose
Active ingredientestradiol
Label structure10 sections

Dosage and administration

Insert one implant under the skin of the ear as directed in the detailed "DIRECTIONS FOR IMPLANTATION" below. WITHDRAWAL PERIODS AND RESIDUE WARNINGS No withdrawal period is required when used according to labeling. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or i...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

AH0948

Elanco™

Compudose™

(estradiol extended-release implants)

Each extended-release implant consists of 25.7 mg estradiol

DESCRIPTION:

DESCRIPTION SECTION

Each Compudose (estradiol extended-release implant) silicone rubber implant contains 25.7 mg estradiol and is coated with sodium bicarbonate.

For subcutaneous ear implantation only.

INDICATIONS FOR USE:

INDICATIONS & USAGE SECTION

  • For increased rate of weight gain for up to 200 days in beef steer calves 2 months of age and older.
  • For increased rate of weight gain for up to 200 days in growing beef steers on pasture (stocker, feeder, and slaughter).
  • For increased rate of weight gain and improved feed efficiency for up to 200 days in growing beef steers and heifers fed in confinement for slaughter.
  • This implant is not approved for repeated implantation (reimplantation) with this or any other cattle ear implant within each separate production phase:
    • Beef steer calves 2 months of age and older
    • Growing beef steers on pasture (stocker, feeder, and slaughter)
    • Growing beef steers and heifers fed in confinement for slaughter

Safety and effectiveness following reimplantation have not been evaluated.

Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established.

Do not use in animals intended for subsequent breeding or in dairy cows.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Insert one implant under the skin of the ear as directed in the detailed "DIRECTIONS FOR IMPLANTATION" below.

WITHDRAWAL PERIODS AND RESIDUE WARNINGS

No withdrawal period is required when used according to labeling. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Implant pellets subcutaneously in ear only. Any other location is a violation of Federal law. Do not attempt salvage of implanted site for human or animal food.

USER SAFETY WARNINGS:

USER SAFETY WARNINGS SECTION

Not for use in humans.

Keep out of reach of children.

ANIMAL SAFETY WARNINGS:

WARNINGS SECTION

Increased sexual activity (bulling, riding and excitability) has been reported in animals implanted with Compudose. Implanted animals should be observed for such signs particularly during the first few days after implanting and animals being excessively ridden (bullers) should be removed to prevent physical injury.

Vaginal and rectal prolapse have been reported in heifers implanted with Compudose.

Udder development, swollen or enlarged vulva and high tailheads may be observed in implanted heifers.

DIRECTIONS FOR IMPLANTATION:

SPL UNCLASSIFIED SECTION

A Compudose (estradiol extended-release implant) or Encore (estradiol extended-release implant) Implanter must be used to implant cattle.

COMPUDOSE/ENCORE IMPLANTER
COMPUDOSE/ENCORE IMPLANTER

Insert one implant under the skin of the ear.

  1. Confine animal in a squeeze chute.
  2. To reduce the possibility of infection and resulting implant loss, hygienic and antiseptic procedures should be followed during implantation. The ear should be clean and dry. The skin should be cleansed with a suitable antiseptic soap and dried prior to implanting. This is particularly important if the ears are contaminated with urine or feces.
  3. To load the Compudose/Encore™ Implanter remove the cartridge from the package, release the latch on the magazine, open and insert the cartridge. (Figure 1)
    Close the magazine and latch. Advance the cartridge to the next implant by inserting the thumb into the magazine opening and turning the cartridge to the next stop.
    Use a sharp needle. The needle should be cleaned and sterilized between each injection by wiping the exterior with a sponge, cloth, or gauze saturated with an appropriate disinfectant.Figure 1Figure 1
  1. The implant should be deposited under the skin on the back side of the middle third of the ear. It should be placed between the skin and cartilage, avoiding major blood vessels.
    Grasping the tip of the ear with one hand and the implanter in the other, penetrate the skin in the outer third of the ear. (see Figure 2)
Figure 2
Figure 2
  • IMPORTANT: Do not penetrate cartilage.
  1. Upon penetration, the needle should be fully inserted (Figure 3) between the skin and cartilage, avoiding major blood vessels. Full insertion of the needle is important to maximize implant retention.
Figure 3
Figure 3
  1. Pull the needle back as the implant is being deposited by squeezing the lever on the implanter grip. Figure 4 shows the implant in proper position in the middle third of the ear where the skin is tight.
  2. Periodically remove the needle from the device and wash it in water. Before reusing, the needle should be disinfected and allowed to dry after shaking vigorously to remove excess water or disinfectant.
Figure 4
Figure 4

To maximize implant retention:

  1. Fully insert the needle.
  2. Deposit the implant in the middle third of the ear where the skin is tight.
  3. Do not deposit the implant where the skin is loose in the third of the ear closest to the head.

The needle has been scientifically designed to maximize retention. When it becomes dull, use a new needle. If the needle is resharpened, sharpen only the point.

Failure to follow antiseptic implanting procedures, particularly when the ears are contaminated with fecal material, may result in infection and excessive implant loss. Implanting cattle during wet weather may increase infection and implant loss.

Carefully check the ears for implant loss approximately 4 weeks after implantation. If loss occurs, reimplant using recommended procedures.

How Supplied:

HOW SUPPLIED SECTION

Compudose Implants are supplied in cartridges of 20 implants each.

Storage Conditions

Store at 15 to 25°C (59-77°F). Do not refrigerate or freeze.

Approved by FDA under NADA # 118-123

Manufactured by a non-sterilizing process.

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED

Compudose, Encore, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2025 Elanco or its affiliates

Manufactured for: Elanco US Inc.
Indianapolis, IN 46221
Product of Germany

Contact Information: To report side effects, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Elanco US Inc., at 1-888-545-5973. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

August 2025                PA104268X

Principal Display Panel - Compudose Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™            AH0948

Compudose™

™

(estradiol extended-release implants)

Each extended-release implant consists of 25.7 mg estradiol

Net contents:
5 CARTRIDGES
Each Cartridge
contains 20 implants
(100 Implants total)

Principal Display Panel - Compudose Carton Label
Principal Display Panel - Compudose Carton Label

Principal Display Panel - Compudose Cartridge Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AH0948

Elanco™

Compudose™

™

(estradiol extended-release implants)

Each implant consists of 25.7 mg estradiol

20 IMPLANTS

Principal Display Panel - Compudose Cartridge Label
Principal Display Panel - Compudose Cartridge Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2108857Compudose 25.7 MG / 0.5 MG Drug ImplantPSN6
2108852estradiol 25.7 MG / oxytetracycline 0.5 MG Drug ImplantPSN6
2108857estradiol 25.7 MG / oxytetracycline 0.5 MG Drug Implant [Compudose]SBD6
2108852estradiol 25.7 MG / oxytetracycline 0.5 MG Drug ImplantSCD6
2108857Compudose 25.7 MG / 0.5 MG Drug ImplantSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-0327-1Compudose20 in 1 CARTRIDGEIMPLANT206
58198-0327-1Compudose5 in 1 CARTONIMPLANT56

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58198-032758198-0327-1

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
estradiol4TI98Z838EACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-02-05full-release2026-06-01 02:42:51

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLA-S Medication Solutionsc8a2d29c-299c-4559-b859-87b303a4af812026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLTrigen Laboratories, LLCe84ad638-6768-41aa-b2b8-e2514ef638812026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ESTRADIOL VAGINALESTRADIOLRedpharm Drug58beabb8-6902-b26a-e063-6294a90a67f82026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
MinivelleESTRADIOLNoven Therapeutics, LLC6c5c47ab-28ee-11e1-bfc2-0800200c9a662026-07-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLRedpharm Drug5718f042-e8c0-b721-e063-6294a90a5bef2026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ESTRADIOLESTRADIOLA-S Medication Solutions5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b2026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLANI Pharmaceuticals, Inc.ff28c624-906d-459c-8b8c-27cb1a664e122026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
Estradiol VaginalESTRADIOLRedpharm Drug546c168d-2a85-69b6-e063-6294a90a22ac2026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ESTRADIOLESTRADIOLBryant Ranch Prepacke6bf2abc-71ae-4e79-a37b-164c98ba746a2026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutions34bcec8e-c7a6-4a1c-9884-4d4efe024bb92026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLREMEDYREPACK INC.41f7a56c-4ce3-4cc6-803e-1ff662efef902026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLREMEDYREPACK INC.59a4b68d-a507-4809-a0c8-fd9799986d122026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutionsba935918-39b3-4b56-bd83-78a29958e6d82026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutions1c38f0d0-a360-4b66-bc0e-7d54e92465a12026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ESTRADIOLESTRADIOLREMEDYREPACK INC.477cb52e-8ce2-491f-94a0-869ff60bf7ab2026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutionseacafc4a-2fa8-403d-8df7-2bc92d73a54f2026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutionsee5460ab-27e7-487a-a89c-bf8735399be62026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLREMEDYREPACK INC.774ee81b-8e29-46af-ab12-7157f63b443b2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstroGelESTRADIOLASCEND Therapeutics US, LLC762ac371-bb8b-47e7-b48f-e80d452c9dd42026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ESTRADIOLESTRADIOLA-S Medication Solutionsafd70875-0a93-40a7-842e-f4359818c2d92026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL

Reported adverse events (FAERS/openFDA)#

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