Penicillin G Potassium

Product NDC: 83634-103
11-digit product format: 836340103
Labeler code: 83634
Product ID: 83634-103_727994cd-436d-4347-a023-5a861abd3264
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: penicillin g potassium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Avenacy Inc.
Application: ANDA065448
Marketing category: ANDA
Marketing start: 2025-02-01
Substance: PENICILLIN G POTASSIUM
Active strength: 20000000 [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-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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A065448-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065448-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065448-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065448-002	AP	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PENICILLIN G POTASSIUM	20000000 [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
969a421e-37d8-499e-9e89-67e210bd5d9d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ea092e41-01a8-4781-b199-b94446808a52	Product name	1	20190205
af7816cd-473e-4681-8ef5-5d4b569ced61	Product name	1	20151014
b37c02b5-6cf5-47fd-aab5-d510a02bbac0	Product name	1	20151014
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0f47357f-4a94-e9f0-4fab-2eb6732c6263	Product name	1	20140508
11e45d82-8b7a-98b7-67b2-842a15f88536	Product name	1	20140508
6ccfe771-a97a-e261-3fb2-bf8e525d1fe0	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83634-103-51	Penicillin G Potassium	1 in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1		1
83634-103-51	Penicillin G Potassium	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83634-103-51	EA - Each	83634-103	936ba8b3-8c81-4368-bc72-af1c0ad0be6f	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83634-103	PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [AVENACY INC.]	1	Current NDC, 2 package rows	20250201_969a421e-37d8-499e-9e89-67e210bd5d9d.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
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
Penicillin G Potassium	PENICILLIN G POTASSIUM	WG Critical Care, LLC	e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448
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 ndc (product): 83634-103
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
863538	penicillin G potassium 1,000,000 UNT/ML Injectable Solution	PSN	969a421e-37d8-499e-9e89-67e210bd5d9d	1
863538	penicillin G potassium 1000000 UNT/ML Injectable Solution	SCD	969a421e-37d8-499e-9e89-67e210bd5d9d	1
863538	Penicillin G K+ 1000000 UNT/ML Injectable Solution	SY	969a421e-37d8-499e-9e89-67e210bd5d9d	1
863538	Penicillin G Pot 1000000 UNT/ML Injectable Solution	SY	969a421e-37d8-499e-9e89-67e210bd5d9d	1
863538	penicillin G potassium 1,000,000 UNT/ML Injectable Solution	SY	969a421e-37d8-499e-9e89-67e210bd5d9d	1
863538	penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable Solution	SY	969a421e-37d8-499e-9e89-67e210bd5d9d	1
863538	penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable Solution	SY	969a421e-37d8-499e-9e89-67e210bd5d9d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83634-103-51	83634010351	1 VIAL in 1 CARTON (83634-103-51) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL	1 vial	2025-02-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Penicillin G Potassium for Injection, USP	Avenacy Inc.	2025-02-01	HUMAN PRESCRIPTION DRUG LABEL	1