Cephalexin

Product NDC
68788-7761
11-digit product format
687887761
Labeler code
68788
Product ID
68788-7761_abbb7fe7-7027-4b14-94f1-127ec2942b58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA065229
Marketing category
ANDA
Marketing start
2020-07-01
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-7761DDiscontinued by firm2026-08-10
excluded packagepackage68788-776168788-7761-1DDiscontinued by firm2026-08-10
excluded packagepackage68788-776168788-7761-2DDiscontinued by firm2026-08-10
excluded packagepackage68788-776168788-7761-3DDiscontinued by firm2026-08-10
excluded packagepackage68788-776168788-7761-4DDiscontinued by firm2026-08-10
excluded packagepackage68788-776168788-7761-5DDiscontinued by firm2026-08-10
excluded packagepackage68788-776168788-7761-6DDiscontinued by firm2026-08-10
excluded packagepackage68788-776168788-7761-7DDiscontinued by firm2026-08-10
excluded packagepackage68788-776168788-7761-8DDiscontinued by firm2026-08-10

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 · 54 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7761-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7761-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7761-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7761-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7761-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7761-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7761-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7761-7d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7761-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7761-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7761-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7761-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7761-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7761-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7761-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7761-7f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7761-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7761-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7761-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7761-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7761-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7761-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7761-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7761-72ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7761-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7761-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7761-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7761-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7761-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7761-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7761-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7761-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7761-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7761-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7761-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7761-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7761-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7761-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7761-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7761-7cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7761-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7761-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7761-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7761-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7761-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7761-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7761-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7761-7cdf11ea48f46…ba0047e9e063…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065229-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25
A065229-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065229-001AB
A065229-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065229-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065229-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065229-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065229-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065229-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065229-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065229-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065229-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065229-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065229-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065229-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065229-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065229-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065229-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065229-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065229-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065229-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065229-002AB1782e0a99824c…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINREMEDYREPACK INC.b3bb8222-161e-4d9c-8e08-7e22ad65bf722026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINREMEDYREPACK INC.8499aa5a-49b1-4555-bd27-6177d92b261d2026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINCoupler LLC508a3401-df0b-0555-e063-6294a90a155a2026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINSportpharm LLC3d5a2665-65da-4b10-9e23-39fc88145da12026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc.13444dc7-7da1-4181-a9ac-d95d4a235e6d2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINLupin Pharmaceuticals, Inc.1d3e6d33-5dc2-498e-8efa-e3c4fca15dff2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINADVANCED RX PHARMACY OF TENNESSEE, LLCaf4abf8b-22cc-da58-e053-2a95a90aa7662024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.a33280d4-7caf-f74b-e053-2a95a90a90c32024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc945552cb-90e4-41fb-afe2-8ee8785e94da2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc.20f8cc57-231c-4d36-a209-ff9e5735d65c2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.728c5212-dbd8-8df5-e053-2a91aa0a95792024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINADVANCED RX PHARMACY OF TENNESSEE, LLCaf10128f-021a-14b7-e053-2a95a90a43652024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc.6032b68f-16d8-41b6-bd2c-86d5406a757a2022-09-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINProficient Rx LPdec3a1ef-1e85-4236-804b-e7a343d3a58f2022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7761-16878877610112 CAPSULE in 1 BOTTLE (68788-7761-1) 12 capsule2020-07-010000-00-00NoNoCurrent
68788-7761-26878877610220 CAPSULE in 1 BOTTLE (68788-7761-2) 20 capsule2020-07-010000-00-00NoNoCurrent
68788-7761-36878877610330 CAPSULE in 1 BOTTLE (68788-7761-3) 30 capsule2020-07-010000-00-00NoNoCurrent
68788-7761-46878877610440 CAPSULE in 1 BOTTLE (68788-7761-4) 40 capsule2020-07-010000-00-00NoNoCurrent
68788-7761-5687887761056 CAPSULE in 1 BOTTLE (68788-7761-5) 6 capsule2020-07-010000-00-00NoNoCurrent
68788-7761-66878877610660 CAPSULE in 1 BOTTLE (68788-7761-6) 60 capsule2020-07-010000-00-00NoNoCurrent
68788-7761-76878877610721 CAPSULE in 1 BOTTLE (68788-7761-7) 21 capsule2020-07-010000-00-00NoNoCurrent
68788-7761-86878877610828 CAPSULE in 1 BOTTLE (68788-7761-8) 28 capsule2020-07-010000-00-00NoNoCurrent