Home NDC 63187-205 Cephalexin
Product NDC 63187-205
11-digit product format 631870205
Labeler code 63187
Product ID 63187-205_379fbc28-1afd-4114-8d06-207a0a33783a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cephalexin
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Proficient Rx LP
Application ANDA062703
Marketing category ANDA
Marketing start 1990-09-30
Substance CEPHALEXIN
Active strength 250 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 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 A062703-001 CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 A062703-002 CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13
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 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062703-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 1987-02-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062703-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB RS 1987-02-13 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 Cephalexin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEPHALEXIN 250 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 63187-205-00 Cephalexin 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 6 63187-205-20 Cephalexin 200 mL in 1 BOTTLE POWDER, FOR SUSPENSION 200 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEPHALEXIN ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] 2 CEPHALEXIN ANHYDROUS ACTIVE MOIETY 5SFF1W6677 CEPHALEXIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CEPHALEXIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CEPHALEXIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] 2 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D CEPHALEXIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEPHALEXIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CEPHALEXIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 CEPHALEXIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CEPHALEXIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-205 CEPHALEXIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] 6 Current NDC, Legacy NDC, 2 package rows 20220710_febab51b-6b48-488a-8fd1-d24400e5df1d.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 · 3 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 63187-205-00 63187020500 100 mL in 1 BOTTLE (63187-205-00) 100 ml 2014-11-03 0000-00-00 No No Current 63187-205-20 63187020520 200 mL in 1 BOTTLE (63187-205-20) 200 ml 2014-11-03 0000-00-00 No No Current