Home NDC 42582-212 Cephalexin
Product NDC 42582-212
11-digit product format 425820212
Labeler code 42582
Product ID 42582-212_919700e3-a422-479c-b37a-9242275a31ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cephalexin
Dosage form CAPSULE
Route ORAL
Labeler Bi-Coastal Pharma International LLC
Application ANDA062713
Marketing category ANDA
Marketing start 2016-02-01
Marketing end 0000-00-00
Substance CEPHALEXIN
Active strength 500 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42582-212-18 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42582-212-10 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42582-212-18 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42582-212-10 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42582-212-18 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42582-212-10 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42582-212-18 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42582-212-10 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42582-212-18 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42582-212-10 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42582-212-18 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42582-212-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42582-212-18 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42582-212-10 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42582-212-18 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42582-212-10 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42582-212-18 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42582-212-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42582-212-18 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42582-212-10 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42582-212-18 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42582-212-10 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42582-212-18 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42582-212-10 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 42582-212-18 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 42582-212-10 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 42582-212-18 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 42582-212-10 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 42582-212-18 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 42582-212-10 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 42582-212-18 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 42582-212-10 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A062713-001 CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 A062713-002 CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15
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 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 42582-212-10 Cephalexin 100 in 1 BOTTLE CAPSULE 100 3 42582-212-18 Cephalexin 500 in 1 BOTTLE CAPSULE 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42582-212 CEPHALEXIN CAPSULE [BI-COASTAL PHARMA INTERNATIONAL LLC] 3 Legacy NDC, 2 package rows 20220118_7b52fd9a-3cb6-4f0e-9e45-17a1eaec926d.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 42582-212-10 42582021210 100 CAPSULE in 1 BOTTLE (42582-212-10) 100 capsule 2016-02-01 0000-00-00 No No Current 42582-212-18 42582021218 500 CAPSULE in 1 BOTTLE (42582-212-18) 500 capsule 2016-02-01 0000-00-00 No No Current