PYtest

Product NDC
42536-6044
11-digit product format
425366044
Labeler code
42536
Product ID
42536-6044_bb840351-2517-431d-8d46-c80ed7c4035d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea, C-14
Dosage form
CAPSULE
Route
ORAL
Labeler
Avent, Inc.
Application
NDA020617
Marketing category
NDA
Marketing start
1997-05-09
Marketing end
0000-00-00
Substance
UREA C-14
Active strength
1 uCi/1
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42536-6044DDiscontinued by firm2026-09-14
excluded packagepackage42536-604442536-6044-1DDiscontinued by firm2026-09-14
excluded packagepackage42536-604442536-6044-2DDiscontinued by firm2026-09-14
excluded packagepackage42536-604442536-6044-3DDiscontinued by firm2026-09-14

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 · 52 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42536-6044-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42536-6044-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42536-6044-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42536-6044-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42536-6044-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42536-6044-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42536-6044-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42536-6044-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42536-6044-3DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42536-6044-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42536-6044-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42536-6044-3DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42536-6044-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42536-6044-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42536-6044-3DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42536-6044-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42536-6044-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42536-6044-3DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42536-6044-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42536-6044-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42536-6044-3DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42536-6044-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42536-6044-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42536-6044-3DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42536-6044-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42536-6044-2DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42536-6044-3DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42536-6044-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42536-6044-2DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42536-6044-3DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42536-6044-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42536-6044-2DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42536-6044-3DDiscontinued by firm367a005e9d99…383a685ebd0f…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42536-6044-3IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42536-6044-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42536-6044-2IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42536-6044-3IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42536-6044-1IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42536-6044-2IInactivated by FDAbd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020617-001PYTESTUREA, C-141uCiCAPSULE / ORALRLD1997-05-09
N020617-002PYTEST KITUREA, C-141uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1997-05-09

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020617-001PYTEST1uCiCAPSULE / ORALRLD1997-05-0984e616aacf4f…
2026-09-14 22:38:342026-08N020617-002PYTEST KIT1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1997-05-0984e616aacf4f…
2026-08-18 06:07:402026-07N020617-001PYTEST1uCiCAPSULE / ORALRLD1997-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020617-002PYTEST KIT1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1997-05-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020617-001PYTEST1uCiCAPSULE / ORALRLD1997-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020617-002PYTEST KIT1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1997-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020617-001PYTEST1uCiCAPSULE / ORALRLD1997-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020617-002PYTEST KIT1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1997-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020617-001PYTEST1uCiCAPSULE / ORALRLD1997-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020617-002PYTEST KIT1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1997-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020617-001PYTEST1uCiCAPSULE / ORALRLD1997-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020617-002PYTEST KIT1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1997-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020617-001PYTEST1uCiCAPSULE / ORALRLD1997-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020617-002PYTEST KIT1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1997-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020617-001PYTEST1uCiCAPSULE / ORALRLD1997-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020617-002PYTEST KIT1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1997-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020617-001PYTEST1uCiCAPSULE / ORALRLD1997-05-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020617-002PYTEST KIT1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1997-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020617-001PYTEST1uCiCAPSULE / ORALRLD, RS1997-05-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020617-002PYTEST KIT1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1997-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020617-001PYTEST1uCiCAPSULE / ORALRLD1997-05-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020617-002PYTEST KIT1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1997-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020617-001PYTEST1uCiCAPSULE / ORALRLD1997-05-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N020617-002PYTEST KIT1uCi **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1997-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020617-001PYTEST1uCiCAPSULE / ORALRLD, RS1997-05-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020617-002PYTEST KIT1uCiCAPSULE / ORALRLD1997-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020617-001PYTEST1uCiCAPSULE / ORALRLD, RS1997-05-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020617-002PYTEST KIT1uCiCAPSULE / ORALRLD1997-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020617-001PYTEST1uCiCAPSULE / ORALRLD, RS1997-05-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020617-002PYTEST KIT1uCiCAPSULE / ORALRLD1997-05-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020617-001PYTEST1uCiCAPSULE / ORALRLD, RS1997-05-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020617-002PYTEST KIT1uCiCAPSULE / ORALRLD1997-05-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020617-001PYTEST1uCiCAPSULE / ORALRLD, RS1997-05-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020617-002PYTEST KIT1uCiCAPSULE / ORALRLD, RS1997-05-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020617-001PYTEST1uCiCAPSULE / ORALRLD, RS1997-05-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020617-002PYTEST KIT1uCiCAPSULE / ORALRLD, RS1997-05-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020617-001PYTEST1uCiCAPSULE / ORALRLD, RS1997-05-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020617-002PYTEST KIT1uCiCAPSULE / ORALRLD, RS1997-05-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020617-001PYTEST1uCiCAPSULE / ORALRLD, RS1997-05-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020617-002PYTEST KIT1uCiCAPSULE / ORALRLD, RS1997-05-0974a2ff9319b5…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Urea, C-14ACTIVE INGREDIENTWBZ6M63TEEPYTEST (UREA, C-14) CAPSULE [AVENT, INC.]1
Urea, C-14ACTIVE MOIETYWBZ6M63TEEPYTEST (UREA, C-14) CAPSULE [AVENT, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42536-6044-1425366044011 BLISTER PACK in 1 PACKAGE (42536-6044-1) > 1 CAPSULE in 1 BLISTER PACK1 blister pack1997-05-090000-00-00NoNoCurrent
42536-6044-24253660440210 CAPSULE in 1 PACKAGE (42536-6044-2) 10 capsule1997-05-090000-00-00NoNoCurrent
42536-6044-342536604403100 CAPSULE in 1 PACKAGE (42536-6044-3) 100 capsule1997-05-090000-00-00NoNoCurrent