FDA.reportPublic FDA data

NP Thyroid 90

Product NDC
53002-5800
Requested package NDC
53002-5800-0
11-digit product format
530025800
Labeler code
53002
Product ID
53002-5800_ddff0636-e467-4893-a63f-9286cdabce4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE, LIOTHYRONINE
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-02-03
Marketing end
0000-00-00
Substance
LEVOTHYROXINE; LIOTHYRONINE
Active strength
57 ug/1; ug/1
Pharmacologic classes
l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-580053002-5800-0IInactivated by FDA2026-10-05

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 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
b42496cd-a994-8ba1-597f-e507aa62246eProduct name520250116
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
01383843-4069-43cf-aa76-dc17a6f9f8c4Product name220230123
978cca7d-a938-4791-8322-da48d90a63efProduct name120230113
65f86ba3-8816-4e12-899b-18290c8de551Product name220210614
f16ab90f-08c2-40be-a543-66d9827cd1f3Product name120210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53002-5800-02025-01-30NP Thyroid 90
53002-5800-32025-01-30NP Thyroid 90
53002-5800-02023-06-08NP Thyroid 90
53002-5800-32023-06-08NP Thyroid 90
53002-5800-02023-01-30NP Thyroid 90
53002-5800-32023-01-30NP Thyroid 90
53002-5800-02020-12-17NP Thyroid 90
53002-5800-32020-12-17NP Thyroid 90
53002-5800-02020-01-31NP Thyroid 90
53002-5800-32020-01-31NP Thyroid 90

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-5800-0NP Thyroid 90100 in 1 BOTTLETABLET1005
53002-5800-3NP Thyroid 9030 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-5800NP THYROID 90 (LEVOTHYROXINE, LIOTHYRONINE) TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_bc6c190c-e813-4fff-b8aa-4848d45a8143.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724437NP Thyroid 90 MG Oral TabletPSNbc6c190c-e813-4fff-b8aa-4848d45a81435
313393thyroid 90 MG (1 1/2 grain) Oral TabletPSNbc6c190c-e813-4fff-b8aa-4848d45a81435
1724437thyroid (USP) 90 MG Oral Tablet [NP Thyroid]SBDbc6c190c-e813-4fff-b8aa-4848d45a81435
313393thyroid (USP) 90 MG Oral TabletSCDbc6c190c-e813-4fff-b8aa-4848d45a81435
313393levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG Oral TabletSYbc6c190c-e813-4fff-b8aa-4848d45a81435
1724437NP Thyroid (levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG) Oral TabletSYbc6c190c-e813-4fff-b8aa-4848d45a81435
1724437NP Thyroid 1 1/2 grain Oral TabletSYbc6c190c-e813-4fff-b8aa-4848d45a81435
1724437NP Thyroid 90 MG Oral TabletSYbc6c190c-e813-4fff-b8aa-4848d45a81435
313393thyroid (USP) 1 1/2 grain Oral TabletSYbc6c190c-e813-4fff-b8aa-4848d45a81435

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-5800-053002580000100 TABLET in 1 BOTTLE (53002-5800-0) 100 tablet2018-10-010000-00-00NoNoCurrent