Penicillin G Potassium

Product NDC
72603-210
11-digit product format
726030210
Labeler code
72603
Product ID
72603-210_9ff380db-0dfa-4fb5-afa1-cb93dc34d83e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin G Potassium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
NorthStar Rx, LLC
Application
ANDA065448
Marketing category
ANDA
Marketing start
2024-03-01
Substance
PENICILLIN G POTASSIUM
Active strength
5000000 [iU]/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
A065448-001PENICILLIN G POTASSIUMPENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18
A065448-002PENICILLIN G POTASSIUMPENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065448-001AP
A065448-002AP

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 UTC2026-02A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18782e0a99824c…
2021-12-28 21:50 UTC2021-12A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18782e0a99824c…

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 UTC2026-02A065448-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065448-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065448-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065448-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065448-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065448-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065448-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065448-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065448-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065448-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065448-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065448-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065448-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065448-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065448-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065448-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065448-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065448-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065448-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065448-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065448-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065448-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065448-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065448-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065448-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065448-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065448-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065448-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065448-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065448-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065448-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065448-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065448-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065448-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065448-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065448-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065448-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065448-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065448-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065448-002AP1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLIN G POTASSIUM5000000 [iU]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VL775ZTH4CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
863538Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8732b7ff-2e47-4f99-aadf-81861b431f4fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea092e41-01a8-4781-b199-b94446808a52Product name120190205
af7816cd-473e-4681-8ef5-5d4b569ced61Product name120151014
b37c02b5-6cf5-47fd-aab5-d510a02bbac0Product name120151014
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0f47357f-4a94-e9f0-4fab-2eb6732c6263Product name120140508
11e45d82-8b7a-98b7-67b2-842a15f88536Product name120140508
6ccfe771-a97a-e261-3fb2-bf8e525d1fe0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-210-01Penicillin G Potassium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION12
72603-210-01Penicillin G Potassium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION12
72603-210-10Penicillin G Potassium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION12
72603-210-10Penicillin G Potassium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-210-01EA - Each72603-210b93a18e2-f962-4a73-bc1a-f28948f009ed12024-07-12
72603-210-10EA - Each72603-2104f02fb7a-d6de-4673-8f54-4cf6a57969cf12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-210PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RX, LLC]2Current NDC, 4 package rows20240629_8732b7ff-2e47-4f99-aadf-81861b431f4f.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMHF Acquisition Co LLC, DBA HealthFirst56ab659e-ad28-028f-e063-6394a90a69432026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448
Penicillin G PotassiumPENICILLIN G POTASSIUMWG Critical Care, LLCe0ced9d8-b9ea-466e-bf2c-10e9cc636f3f2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448
PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMHF Acquisition Co LLC, DBA HealthFirst50c7500f-be06-01af-e063-6294a90a01352026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448
Penicillin G PotassiumPENICILLIN G POTASSIUMAvenacy Inc.969a421e-37d8-499e-9e89-67e210bd5d9d2025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448
Penicillin G PotassiumPENICILLIN G POTASSIUMAthenex Pharmaceutical Division, LLC.1442486a-05d6-4dce-8b95-857a30f478c22025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448
Penicillin G PotassiumPENICILLIN G POTASSIUMSagent Pharmaceuticalsfb2f3afe-0072-4383-bad8-9da9e94db4f22024-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448
Penicillin G PotassiumPENICILLIN G POTASSIUMNorthStar Rx, LLC8732b7ff-2e47-4f99-aadf-81861b431f4f2024-06-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448
ndc (product): 72603-210

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionPSN8732b7ff-2e47-4f99-aadf-81861b431f4f2
863538penicillin G potassium 1000000 UNT/ML Injectable SolutionSCD8732b7ff-2e47-4f99-aadf-81861b431f4f2
863538Penicillin G K+ 1000000 UNT/ML Injectable SolutionSY8732b7ff-2e47-4f99-aadf-81861b431f4f2
863538Penicillin G Pot 1000000 UNT/ML Injectable SolutionSY8732b7ff-2e47-4f99-aadf-81861b431f4f2
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionSY8732b7ff-2e47-4f99-aadf-81861b431f4f2
863538penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable SolutionSY8732b7ff-2e47-4f99-aadf-81861b431f4f2
863538penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable SolutionSY8732b7ff-2e47-4f99-aadf-81861b431f4f2
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionPSN50c7500f-be06-01af-e063-6294a90a01351
863538penicillin G potassium 1000000 UNT/ML Injectable SolutionSCD50c7500f-be06-01af-e063-6294a90a01351
863538Penicillin G K+ 1000000 UNT/ML Injectable SolutionSY50c7500f-be06-01af-e063-6294a90a01351
863538Penicillin G Pot 1000000 UNT/ML Injectable SolutionSY50c7500f-be06-01af-e063-6294a90a01351
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionSY50c7500f-be06-01af-e063-6294a90a01351
863538penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable SolutionSY50c7500f-be06-01af-e063-6294a90a01351
863538penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable SolutionSY50c7500f-be06-01af-e063-6294a90a01351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-210-01726030210011 VIAL in 1 CARTON (72603-210-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL1 vial2024-03-01NoNoCurrent
72603-210-107260302101010 VIAL in 1 CARTON (72603-210-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2024-03-01NoNoCurrent