Home NDC 44004-801 Spectracef
Product NDC 44004-801
11-digit product format 440040801
Labeler code 44004
Product ID 44004-801_f99cc35f-6ffa-4f2e-bcdf-e51bb9a17c0d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefditoren pivoxil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Vansen Pharma Inc.
Application NDA021222
Marketing category NDA
Marketing start 2013-02-05
Marketing end 0000-00-00
Substance CEFDITOREN PIVOXIL
Active strength 200 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 44004-801-20 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 44004-801-20 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 44004-801-20 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 44004-801-20 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 44004-801-20 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 44004-801-20 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 44004-801-20 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 44004-801-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 44004-801-20 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 44004-801-20 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 44004-801-20 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 44004-801-20 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 44004-801-20 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 44004-801-20 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 44004-801-20 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 44004-801-20 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 44004-801-20 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 44004-801-20 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 44004-801-20 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 44004-801-20 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 44004-801-20 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 44004-801-20 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021222-001 SPECTRACEF CEFDITOREN PIVOXIL 200MG TABLET / ORAL 2001-08-29 N021222-002 SPECTRACEF CEFDITOREN PIVOXIL 400MG TABLET / ORAL 2008-07-21
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 · 82 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 2026-02-19 14:30 UTC 2026-02 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021222-001 SPECTRACEF 200MG TABLET / ORAL 2001-08-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021222-002 SPECTRACEF 400MG TABLET / ORAL 2008-07-21 782e0a99824c…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44004-801-20 Spectracef 20 in 1 BLISTER PACK TABLET, FILM COATED 20 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFDITOREN PIVOXIL ACTIVE INGREDIENT 78THA212DH SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 CEFDITOREN ACTIVE MOIETY 81QS09V3YW SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 SODIUM CASEINATE INACTIVE INGREDIENT 7473P66J9E SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 SODIUM TRIPOLYPHOSPHATE INACTIVE INGREDIENT 5HK03SA80J SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44004-801 SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] 2 Legacy NDC, 1 package rows 20130605_1c90b649-5536-417c-82cb-89663137f14f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 44004-801-20 44004080120 20 in 1 BLISTER PACK Historical