Penicillin G Potassium

Product NDC: 44567-310
11-digit product format: 445670310
Labeler code: 44567
Product ID: 44567-310_b7d807b1-f742-4e96-bb34-3e832b985303
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin G Potassium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: WG Critical Care, LLC
Application: ANDA065149
Marketing category: ANDA
Marketing start: 2012-05-10
Substance: PENICILLIN G POTASSIUM
Active strength: 1000000 [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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A065149-001	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23
A065149-002	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23
A065149-003	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065149-002	AP
A065149-003	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 4 · 129 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	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A065149-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065149-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065149-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065149-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065149-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065149-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065149-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065149-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065149-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065149-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065149-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065149-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065149-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065149-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065149-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065149-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065149-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065149-003	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065149-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065149-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065149-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A065149-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065149-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065149-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065149-002	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065149-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065149-002	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065149-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065149-002	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065149-003	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065149-002	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065149-003	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065149-002	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065149-003	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065149-002	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065149-003	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065149-002	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065149-003	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065149-002	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A065149-003	AP	1	`f41ea6bd6efb…`

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	1000000 [iU]/1

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
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
44567-310-10	Penicillin G Potassium	10 in 1 TRAY	INJECTION, POWDER, FOR SOLUTION	10		11
44567-310-10	Penicillin G Potassium	1 in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PENICILLIN G POTASSIUM	ACTIVE INGREDIENT	VL775ZTH4C	PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]	3
PENICILLIN G	ACTIVE MOIETY	Q42T66VG0C	PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44567-310	PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]	10	Current NDC, Legacy NDC, 2 package rows	20250502_e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f.zip

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	e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f	11
863538	penicillin G potassium 1000000 UNT/ML Injectable Solution	SCD	e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f	11
863538	Penicillin G K+ 1000000 UNT/ML Injectable Solution	SY	e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f	11
863538	Penicillin G Pot 1000000 UNT/ML Injectable Solution	SY	e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f	11
863538	penicillin G potassium 1,000,000 UNT/ML Injectable Solution	SY	e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f	11
863538	penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable Solution	SY	e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f	11
863538	penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable Solution	SY	e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44567-310-10	44567031010	10 VIAL in 1 TRAY (44567-310-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL	10 vial	2012-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Penicillin G Potassium for Injection, USP	WG Critical Care, LLC \| Mitim s.r.l \| IBI Instituto Biochimico Italiano Giovanni Lorenzini SpA	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	13