Home NDC 11528-010-01 COVARYX
Product NDC 11528-010
Requested package NDC 11528-010-01
11-digit product format 115280010
Labeler code 11528
Product ID 11528-010_9d03bf4c-e54a-795d-e053-2a95a90a9e02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE
Dosage form TABLET, COATED
Route ORAL
Labeler CENTRIX PHARMACEUTICAL, INC,
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2007-04-01
Marketing end 0000-00-00
Substance ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE
Active strength 1 mg/1; mg/1
Pharmacologic classes Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11528-010-01 COVARYX 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESTROGENS, ESTERIFIED ACTIVE INGREDIENT 3ASP8Q3768 COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 METHYLTESTOSTERONE ACTIVE INGREDIENT V9EFU16ZIF COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 ESTROGENS, ESTERIFIED ACTIVE MOIETY 3ASP8Q3768 COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 METHYLTESTOSTERONE ACTIVE MOIETY V9EFU16ZIF COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11528-010 COVARYX HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED COVARYX (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CENTRIX PHARMACEUTICAL, INC,] 2 Legacy NDC, 1 package rows 20200128_e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 705919 Covaryx 1.25 MG / 2.5 MG Oral Tablet PSN e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae 2 705921 Covaryx HS 0.625 MG / 1.25 MG Oral Tablet PSN e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae 2 238006 estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral Tablet PSN e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae 2 197670 estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral Tablet PSN e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae 2 705921 estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral Tablet [Covaryx] SBD e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae 2 705919 estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral Tablet [Covaryx] SBD e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae 2 238006 estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral Tablet SCD e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae 2 197670 estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral Tablet SCD e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae 2 705921 Covaryx (estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG) Oral Tablet SY e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae 2 705919 Covaryx (estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG) Oral Tablet SY e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae 2 705921 Covaryx HS (estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG) Oral Tablet SY e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae 2 197670 EEMT DS Oral Tablet SY e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae 2 238006 EEMT HS Oral Tablet SY e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 11528-010-01 11528001001 100 TABLET, COATED in 1 BOTTLE, PLASTIC (11528-010-01) 2007-04-01 0000-00-00 No No Current