Home NDC 68475-201 Penicillamine
Product NDC 68475-201
11-digit product format 684750201
Labeler code 68475
Product ID 68475-201_0ee5ea02-a892-408f-aa5d-42ab034bdfc4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Penicillamine
Dosage form CAPSULE
Route ORAL
Labeler Navinta LLC
Application ANDA214363
Marketing category ANDA
Marketing start 2022-01-01
Substance PENICILLAMINE
Active strength 250 mg/1
Pharmacologic classes Antirheumatic Agent [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214363-001 PENICILLAMINE PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214363-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214363-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-10-08 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Penicillamine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PENICILLAMINE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GNN1DV99GX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198070 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68475-201-01 Penicillamine 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68475-201 PENICILLAMINE CAPSULE [NAVINTA LLC] 2 Current NDC, Legacy NDC, 1 package rows 20221213_064fb48d-aa34-4e52-9295-10f2ca4c77dc.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68475-201-01 68475020101 100 CAPSULE in 1 BOTTLE (68475-201-01) 100 capsule 2022-01-01 0000-00-00 No No Current