Home NDC 70709-102 AAGYLUR
Product NDC 70709-102
11-digit product format 707090102
Labeler code 70709
Product ID 70709-102_97662326-3312-4ed1-9036-77e250e34cda
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Penicillamine
Dosage form CAPSULE
Route ORAL
Labeler Cycle Pharmaceuticals Ltd.
Application ANDA213293
Marketing category ANDA
Marketing start 2025-09-25
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 A213293-001 PENICILLAMINE PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213293-001 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 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213293-001 PENICILLAMINE 250MG CAPSULE / ORAL AB 2021-08-19 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base AAGYLUR
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198070 Internal RxNorm lookup 2723908 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 70709-102-10 AAGYLUR 100 in 1 BOTTLE CAPSULE 100 1
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AAGYLUR PENICILLAMINE Cycle Pharmaceuticals Ltd. ddbd84a9-1c39-42e0-a271-138784e1dc58 2024-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213293 application number: ANDA213293 ndc (product): 70709-102
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70709-102-10 70709010210 100 CAPSULE in 1 BOTTLE (70709-102-10) 100 capsule 2025-09-25 No No Current