FDA.reportPublic FDA data

NP Thyroid 60

Product NDC
53002-1029
Requested package NDC
53002-1029-3
11-digit product format
530021029
Labeler code
53002
Product ID
53002-1029_7dbc2cef-4da8-4e16-9ea3-1a9cc5fc4a90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE, LIOTHYRONINE
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-11-11
Marketing end
0000-00-00
Substance
LEVOTHYROXINE; LIOTHYRONINE
Active strength
38 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 packagepackage53002-102953002-1029-3IInactivated 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 · 17 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…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
53002-1029-02023-01-30NP Thyroid 60
53002-1029-32023-01-30NP Thyroid 60
53002-1029-02020-12-15NP Thyroid 60
53002-1029-32020-12-15NP Thyroid 60
53002-1029-02020-01-31NP Thyroid 60
53002-1029-32020-01-31NP Thyroid 60

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1029-0NP Thyroid 60100 in 1 BOTTLETABLET1003
53002-1029-3NP Thyroid 6030 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1029NP THYROID 60 (LEVOTHYROXINE, LIOTHYRONINE) TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20201217_4ec69e07-65ad-4547-98ca-cf83cf9f423f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724481NP Thyroid 60 MG Oral TabletPSN4ec69e07-65ad-4547-98ca-cf83cf9f423f3
313391thyroid 60 MG (1 grain) Oral TabletPSN4ec69e07-65ad-4547-98ca-cf83cf9f423f3
1724481thyroid (USP) 60 MG Oral Tablet [NP Thyroid]SBD4ec69e07-65ad-4547-98ca-cf83cf9f423f3
313391thyroid (USP) 60 MG Oral TabletSCD4ec69e07-65ad-4547-98ca-cf83cf9f423f3
313391levothyroxine sodium 38 MCG / liothyronine sodium 9 MCG Oral TabletSY4ec69e07-65ad-4547-98ca-cf83cf9f423f3
1724481NP Thyroid (levothyroxine sodium 38 MCG / liothyronine sodium 9 MCG) Oral TabletSY4ec69e07-65ad-4547-98ca-cf83cf9f423f3
1724481NP Thyroid 1 grain Oral TabletSY4ec69e07-65ad-4547-98ca-cf83cf9f423f3
1724481NP Thyroid 60 MG Oral TabletSY4ec69e07-65ad-4547-98ca-cf83cf9f423f3
313391thyroid (USP) 1 grain Oral TabletSY4ec69e07-65ad-4547-98ca-cf83cf9f423f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1029-35300210290330 TABLET in 1 BOTTLE (53002-1029-3) 30 tablet2018-10-010000-00-00NoNoCurrent