PENICILLIN G POTASSIUM

Product NDC: 51662-1709
11-digit product format: 516621709
Labeler code: 51662
Product ID: 51662-1709_56ab659e-ad29-028f-e063-6394a90a6943
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PENICILLIN G POTASSIUM
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA065448
Marketing category: ANDA
Marketing start: 2024-12-01
Substance: PENICILLIN G POTASSIUM
Active strength: 5000000 [iU]/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065448-001	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP		2009-08-18
A065448-002	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP		2009-08-18

Therapeutic equivalence codes#

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

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

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065448-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065448-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065448-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065448-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065448-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065448-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065448-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065448-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065448-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065448-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065448-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065448-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065448-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065448-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065448-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065448-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065448-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065448-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065448-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065448-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065448-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065448-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065448-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065448-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065448-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065448-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065448-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065448-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065448-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065448-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065448-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065448-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065448-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065448-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065448-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065448-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065448-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065448-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065448-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065448-002	AP	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: PENICILLIN G POTASSIUM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PENICILLIN G POTASSIUM	5000000 [iU]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VL775ZTH4C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
56ab659e-ad28-028f-e063-6394a90a6943	Available on FDA.report

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	HF Acquisition Co LLC, DBA HealthFirst	56ab659e-ad28-028f-e063-6394a90a6943	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448 ndc (product): 51662-1709
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	HF Acquisition Co LLC, DBA HealthFirst	50c7500f-be06-01af-e063-6294a90a0135	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448
Penicillin G Potassium	PENICILLIN G POTASSIUM	Avenacy Inc.	969a421e-37d8-499e-9e89-67e210bd5d9d	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448
Penicillin G Potassium	PENICILLIN G POTASSIUM	Athenex Pharmaceutical Division, LLC.	1442486a-05d6-4dce-8b95-857a30f478c2	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448
Penicillin G Potassium	PENICILLIN G POTASSIUM	Sagent Pharmaceuticals	fb2f3afe-0072-4383-bad8-9da9e94db4f2	2024-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448
Penicillin G Potassium	PENICILLIN G POTASSIUM	NorthStar Rx, LLC	8732b7ff-2e47-4f99-aadf-81861b431f4f	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VL775ZTH4C	PENICILLIN G POTASSIUM	113-98-4	PENICILLIN G POTASSIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51662-1709-1	51662170901	1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (51662-1709-1)	2024-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PENICILLIN G POTASSIUM - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	1