Home NDC 69097-517 Cyclophosphamide
Product NDC 69097-517
11-digit product format 690970517
Labeler code 69097
Product ID 69097-517_11c7b59d-18e5-4efb-bc77-5877d9b89bb1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclophosphamide
Dosage form CAPSULE
Route ORAL
Labeler Cipla USA Inc.
Application ANDA211608
Marketing category ANDA
Marketing start 2019-01-18
Substance CYCLOPHOSPHAMIDE
Active strength 50 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 69097-517 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69097-517 69097-517-07 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211608-001 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 A211608-002 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 84 observed 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 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211608-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2019-01-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211608-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2019-01-18 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cyclophosphamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOPHOSPHAMIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8N3DW7272P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1437968 Internal RxNorm lookup 1437969 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 69097-517-07 Cyclophosphamide 100 in 1 BOTTLE CAPSULE 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-517 CYCLOPHOSPHAMIDE CAPSULE [CIPLA USA INC.] 6 Current NDC, Legacy NDC, 1 package rows 20250117_0e1cb955-99c8-4fe5-89d1-399c8e52174e.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 69097-517-07 69097051707 100 CAPSULE in 1 BOTTLE (69097-517-07) 100 capsule 2019-01-18 0000-00-00 No No Current