Home NDC 66887-004-10 Testopel
Product NDC 66887-004
Requested package NDC 66887-004-10
11-digit product format 668870004
Labeler code 66887
Product ID 66887-004_0a13cf12-e51e-4d3d-a7c4-ea74712e6db2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name testosterone
Dosage form PELLET
Route SUBCUTANEOUS
Labeler Endo USA, Inc.
Application ANDA080911
Marketing category ANDA
Marketing start 2014-10-31
Substance TESTOSTERONE
Active strength 75 mg/1
Pharmacologic classes Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080911-001 TESTOPEL TESTOSTERONE 75MG PELLET / IMPLANTATION RS, Approved before 1982
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A080911-001 TESTOPEL 75MG PELLET / IMPLANTATION RS, Approved before 1982 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Testopel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TESTOSTERONE 75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3XMK78S47O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 318240 Internal RxNorm lookup 404405 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66887-004-01 Testopel 1 in 1 AMPULE PELLET 1 28 66887-004-10 Testopel 10 in 1 BOX PELLET 10 28 66887-004-20 Testopel 100 in 1 BOX PELLET 100 28
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66887-004 TESTOPEL (TESTOSTERONE) PELLET [ENDO USA, INC.] 24 Current NDC, Legacy NDC, 3 package rows 20240425_03b9c0b1-5884-11e4-8ed6-0800200c9a66.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66887-004-10 66887000410 10 AMPULE in 1 BOX (66887-004-10) / 1 PELLET in 1 AMPULE (66887-004-01) 10 ampule 2014-10-31 0000-00-00 No No Current