Penicillin V Potassium

Product NDC
43063-780
11-digit product format
430630780
Labeler code
43063
Product ID
43063-780_2c25446b-961e-ee26-e063-6394a90a7385
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090549
Marketing category
ANDA
Marketing start
2013-10-11
Substance
PENICILLIN V POTASSIUM
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [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-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…

Additional Listing Data#

Finished product
Yes
Brand name base
Penicillin V Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLIN V POTASSIUM500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
146T0TU1JBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
834102Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3f5947d-0dd3-4b50-93a2-bc8325180978Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-780-06Penicillin V Potassium6 in 1 BOTTLE, PLASTICTABLET, FILM COATED623
43063-780-15Penicillin V Potassium15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1523
43063-780-20Penicillin V Potassium20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2023
43063-780-28Penicillin V Potassium28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2823
43063-780-30Penicillin V Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3023
43063-780-40Penicillin V Potassium40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-780-06EA - Each43063-7801f85612e-3e60-47a5-bab1-bcd2f47342b012020-09-14
43063-780-15EA - Each43063-7805281fa55-9ded-4706-9086-96d8d3970b3212017-10-13
43063-780-20EA - Each43063-7808f73e1dc-03f2-4436-b71f-f2124319304a12017-11-06
43063-780-28EA - Each43063-780d46eb488-058d-4258-9f4e-621947e8832c12018-04-19
43063-780-30EA - Each43063-780f7f6506f-67c8-4885-8387-5a2e5292a51912017-09-11
43063-780-40EA - Each43063-780a3c53b31-581d-4299-b1b2-b660f602c44c12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-780PENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 6 package rows20250121_f3f5947d-0dd3-4b50-93a2-bc8325180978.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
ndc (product): 43063-780
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSNf3f5947d-0dd3-4b50-93a2-bc832518097823
834102penicillin V potassium 500 MG Oral TabletSCDf3f5947d-0dd3-4b50-93a2-bc832518097823
834102Penicillin V K+ 500 MG Oral TabletSYf3f5947d-0dd3-4b50-93a2-bc832518097823
834102Penicillin V Pot 500 MG Oral TabletSYf3f5947d-0dd3-4b50-93a2-bc832518097823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-780-06430630780066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-780-06) 2020-08-040000-00-00NoNoCurrent
43063-780-154306307801515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-780-15) 2017-09-010000-00-00NoNoCurrent
43063-780-204306307802020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-780-20) 2017-09-270000-00-00NoNoCurrent
43063-780-284306307802828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-780-28) 2018-03-050000-00-00NoNoCurrent
43063-780-304306307803030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-780-30) 2018-08-070000-00-00NoNoCurrent
43063-780-404306307804040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-780-40) 2018-08-070000-00-00NoNoCurrent