Home NDC 70748-153-01 Penicillamine
Product NDC 70748-153
Requested package NDC 70748-153-01
11-digit product format 707480153
Labeler code 70748
Product ID 70748-153_99f3ca78-1663-47a1-9ed3-9c4eaa9f0271
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Penicillamine
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA212933
Marketing category ANDA
Marketing start 2021-03-01
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 1 .
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 A212933-001 PENICILLAMINE PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212933-001 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 2026-02-19 14:30 UTC 2026-02 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212933-001 PENICILLAMINE 250MG TABLET / ORAL AB 2020-11-30 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 198071 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 70748-153-01 Penicillamine 100 in 1 BOTTLE TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70748-153 PENICILLAMINE TABLET [LUPIN PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20230105_f6ecaf47-902f-4378-b524-7a88f20ba138.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 70748-153-01 70748015301 100 TABLET in 1 BOTTLE (70748-153-01) 100 tablet 2021-03-01 0000-00-00 No No Current