cephalexin

Product NDC
70934-034
11-digit product format
709340034
Labeler code
70934
Product ID
70934-034_7e54d9b3-526d-84df-e053-2991aa0a542d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc.
Application
ANDA065248
Marketing category
ANDA
Marketing start
2017-07-27
Marketing end
2020-07-31
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-034DDiscontinued by firm2026-08-03
excluded packagepackage70934-03470934-034-14DDiscontinued by firm2026-08-03
excluded packagepackage70934-03470934-034-20DDiscontinued by firm2026-08-03
excluded packagepackage70934-03470934-034-21DDiscontinued by firm2026-08-03
excluded packagepackage70934-03470934-034-28DDiscontinued by firm2026-08-03
excluded packagepackage70934-03470934-034-30DDiscontinued by firm2026-08-03
excluded packagepackage70934-03470934-034-40DDiscontinued by firm2026-08-03
excluded packagepackage70934-03470934-034-94DDiscontinued by firm2026-08-03

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 2 · 96 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 packagepackage70934-034-94d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-034-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-034-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-034-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-034-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-034-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-034-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-034-94f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-034-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-034-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-034-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-034-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-034-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-034-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-034-942ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-034-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-034-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-034-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-034-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-034-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-034-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-034-94a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-034-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-034-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-034-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-034-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-034-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-034-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-034-94cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-034-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-034-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-034-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-034-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-034-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-034-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-034-94cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-034-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-034-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-034-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-034-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-034-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-034-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-034-94302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-034-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-034-28302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-034-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-034-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-034-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-034-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70934-034-94ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70934-034-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70934-034-28ed331223b511…672a5bd82f5f…

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
A065248-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28
A065248-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065248-001AB
A065248-002AB

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 UTC2026-02A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28782e0a99824c…

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 UTC2026-02A065248-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065248-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065248-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065248-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065248-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065248-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065248-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065248-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065248-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065248-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065248-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065248-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065248-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065248-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065248-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065248-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065248-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065248-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065248-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065248-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065248-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065248-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065248-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065248-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065248-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065248-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065248-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065248-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065248-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065248-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065248-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065248-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065248-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065248-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065248-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065248-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065248-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065248-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065248-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065248-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-034-14EA - Each70934-034cd640932-7c5b-4ec2-b220-5c972db15b7512018-01-12
70934-034-20EA - Each70934-034641c1640-fbba-44f5-8aeb-800e8e5dbab712018-01-12
70934-034-21EA - Each70934-034ba752833-17a6-412f-bd17-11bbb6abeaef12018-01-12
70934-034-28EA - Each70934-0343c725ff8-37e5-472f-9039-ec0a411e832a12018-01-12
70934-034-30EA - Each70934-03459e13f00-068f-4660-a3d0-030af94bba9612018-01-12
70934-034-40EA - Each70934-034c682a742-807f-4f02-a44b-62e41ebc4bf012018-01-12
70934-034-94EA - Each70934-034de92cc38-700d-4e76-9dfc-be5c53a3e5e912018-01-12