FDA.reportPublic FDA data

Penicillamine

Product NDC
60505-4696
Requested package NDC
60505-4696-1
11-digit product format
605054696
Labeler code
60505
Product ID
60505-4696_8eefb301-f1c7-c392-1c6f-9a069ea34340
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillamine
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA213310
Marketing category
ANDA
Marketing start
2020-06-26
Marketing end
0000-00-00
Substance
PENICILLAMINE
Active strength
250 mg/1
Pharmacologic classes
Antirheumatic Agent [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-469660505-4696-1DDiscontinued by firm2026-08-17

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60505-469660505-4696-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213310-001PENICILLAMINEPENICILLAMINE250MGCAPSULE / ORAL2020-04-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213310-001PENICILLAMINE250MGCAPSULE / ORAL2020-04-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213310-001PENICILLAMINE250MGCAPSULE / ORAL2020-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213310-001PENICILLAMINE250MGCAPSULE / ORAL2020-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213310-001PENICILLAMINE250MGCAPSULE / ORALAB2020-04-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213310-001PENICILLAMINE250MGCAPSULE / ORAL2020-04-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A213310-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213310-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213310-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213310-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213310-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213310-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213310-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213310-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213310-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213310-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213310-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213310-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213310-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213310-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213310-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213310-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213310-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213310-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A213310-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213310-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213310-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213310-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213310-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213310-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213310-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213310-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213310-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213310-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213310-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A213310-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213310-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213310-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213310-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213310-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4696-1EA - Each60505-46962e42bba5-7f9e-4fe5-aeaa-fd97fae3766512020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4696PENICILLAMINE (PENICILLAMINE) CAPSULE [APOTEX CORP.]4Legacy NDC20240423_4afb20ee-eb3f-1937-ffa4-5d3228e82688.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-4696-160505469601100 CAPSULE in 1 BOTTLE (60505-4696-1) 100 capsule2020-06-260000-00-00NoNoCurrent