Home NDC 62135-480-49 Cephalexin
Product NDC 62135-480
Requested package NDC 62135-480-49
11-digit product format 621350480
Labeler code 62135
Product ID 62135-480_459b5240-6bbf-1d2d-e063-6294a90aac45
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cephalexin
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA065336
Marketing category ANDA
Marketing start 2018-02-28
Substance CEPHALEXIN
Active strength 125 mg/5mL
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065336-001 CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 A065336-002 CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25
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 · 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 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065336-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065336-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2007-07-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cephalexin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEPHALEXIN 125 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination OBN7UDS42Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309110 Internal RxNorm lookup 309113 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 62135-480-42 Cephalexin 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 4 62135-480-49 Cephalexin 200 mL in 1 BOTTLE POWDER, FOR SUSPENSION 200 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-480 CEPHALEXIN POWDER, FOR SUSPENSION [CHARTWELL RX, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241016_8a09bccd-1864-4dc3-9c31-6187d8e0fc99.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 62135-480-49 62135048049 200 mL in 1 BOTTLE (62135-480-49) 200 ml 2022-02-01 0000-00-00 No No Current