Penicillin V Potassium

Product NDC
68071-2515
Requested package NDC
68071-2515-6
11-digit product format
680712515
Labeler code
68071
Product ID
68071-2515_ca543957-4c75-cf88-e053-2a95a90a27d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090549
Marketing category
ANDA
Marketing start
2013-10-11
Marketing end
0000-00-00
Substance
PENICILLIN V POTASSIUM
Active strength
500 mg/1
Pharmacologic classes
Penicillins [CS],Penicillin-class Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68071-251568071-2515-6DDiscontinued by firm2026-08-07

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A090549-001PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11
A090549-002PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090549-001AB
A090549-002AB

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 UTC2026-02A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11782e0a99824c…

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 UTC2026-02A090549-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090549-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090549-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090549-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090549-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090549-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090549-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090549-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090549-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090549-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090549-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090549-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090549-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090549-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090549-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090549-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090549-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090549-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090549-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090549-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090549-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090549-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090549-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090549-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090549-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090549-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090549-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090549-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090549-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090549-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090549-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090549-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090549-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090549-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090549-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090549-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090549-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090549-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090549-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090549-002AB1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9c9e02f7-1420-b137-8de0-89820016e6caProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2515-2Penicillin V Potassium20 in 1 BOTTLETABLET, FILM COATED201
68071-2515-3Penicillin V Potassium30 in 1 BOTTLETABLET, FILM COATED301
68071-2515-4Penicillin V Potassium40 in 1 BOTTLETABLET, FILM COATED401
68071-2515-6Penicillin V Potassium60 in 1 BOTTLETABLET, FILM COATED601
68071-2515-9Penicillin V Potassium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2515PENICILLIN V POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 5 package rows20210825_ca542d8c-5aa2-b975-e053-2a95a90a9c46.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.5f0759cc-c553-49b9-9049-80e7137589582026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMBryant Ranch Prepack609c3e26-9220-4f3c-b393-a2b41b68de6c2026-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.ceddc406-4a17-471f-917e-63b4b03779ea2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.a251a769-280e-4024-ad7a-3177463258182025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMBryant Ranch Prepackbdffe8fe-e6e0-4c08-894c-0653605ff4332025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPreferred Pharmaceuticals Inc.56192625-0564-4131-94b2-8b9c6a0b53b02025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.8d98ea77-f237-4b93-87fa-41f556436ab52025-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.7aef4c8b-aee7-453d-bb6f-fce8e4588e3b2025-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.fbd3f219-d052-fd00-e053-6294a90a66ac2025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.f3f5947d-0dd3-4b50-93a2-bc83251809782025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMA-S Medication Solutions93c1177c-35da-464b-be90-bb18fe9bd27d2024-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMHikma Pharmaceuticals USA Inc.dc33f7a4-348b-4b4c-a5f2-c4f908fda4aa2024-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMA-S Medication Solutionse4642fb3-2db9-49d3-8fd4-ceb750f704372023-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2515-66807125150660 TABLET, FILM COATED in 1 BOTTLE (68071-2515-6) 2021-08-240000-00-00NoNoCurrent