PENICILLIN G POTASSIUM

Product NDC: 0338-1021
Requested package NDC: 0338-1021-41
11-digit product format: 003381021
Labeler code: 0338
Product ID: 0338-1021_b7e68f35-c49a-4137-841d-902b1b2b400a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PENICILLIN G
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA050638
Marketing category: NDA
Marketing start: 1990-06-25
Substance: PENICILLIN G POTASSIUM
Active strength: 1000000 [iU]/50mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0338-1021	0338-1021-41	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	PENICILLIN G POTASSIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25
N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	PENICILLIN G POTASSIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25
N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	PENICILLIN G POTASSIUM	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050638-002	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	40,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050638-003	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	60,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050638-001	PENICILLIN G POTASSIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	1990-06-25	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
ea092e41-01a8-4781-b199-b94446808a52	Product name	1	20190205
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
af7816cd-473e-4681-8ef5-5d4b569ced61	Product name	1	20151014
b37c02b5-6cf5-47fd-aab5-d510a02bbac0	Product name	1	20151014
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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
0338-1021-41	PENICILLIN G POTASSIUM	50 mL in 1 BAG	INJECTION, SOLUTION	50		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-1021-41	ML - Milliliter	0338-1021	62210427-c92c-4c60-bbd3-852d8ef9ad2d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PENICILLIN G POTASSIUM	ACTIVE INGREDIENT	VL775ZTH4C	PENICILLIN G POTASSIUM (PENICILLIN G) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
PENICILLIN G	ACTIVE MOIETY	Q42T66VG0C	PENICILLIN G POTASSIUM (PENICILLIN G) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	PENICILLIN G POTASSIUM (PENICILLIN G) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	PENICILLIN G POTASSIUM (PENICILLIN G) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PENICILLIN G POTASSIUM (PENICILLIN G) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	PENICILLIN G POTASSIUM (PENICILLIN G) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	PENICILLIN G POTASSIUM (PENICILLIN G) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-1021	PENICILLIN G POTASSIUM (PENICILLIN G) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	17	Current NDC, Legacy NDC, 1 package rows	20250109_9e58122f-5c75-4905-a774-d3a4dae4ff8c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PENICILLIN G POTASSIUM	PENICILLIN G	Baxter Healthcare Corporation	9e58122f-5c75-4905-a774-d3a4dae4ff8c	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050638 application number: NDA050638 ndc (package): 0338-1021-41 ndc (product): 0338-1021 ndc11 (package): 00338102141

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VL775ZTH4C	PENICILLIN G POTASSIUM	113-98-4	PENICILLIN G POTASSIUM
Q42T66VG0C	PENICILLIN G	61-33-6	PENICILLIN G

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
207390	penicillin G potassium 1,000,000 UNT in 50 ML Injection	PSN	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
204466	penicillin G potassium 2,000,000 UNT in 50 ML Injection	PSN	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
207391	penicillin G potassium 3,000,000 UNT in 50 ML Injection	PSN	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
207390	50 ML penicillin G potassium 20000 UNT/ML Injection	SCD	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
204466	50 ML penicillin G potassium 40000 UNT/ML Injection	SCD	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
207391	50 ML penicillin G potassium 60000 UNT/ML Injection	SCD	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
207390	50 ML Penicillin G K+ 20000 UNT/ML Injection	SY	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
204466	50 ML Penicillin G K+ 40000 UNT/ML Injection	SY	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
207391	50 ML Penicillin G K+ 60000 UNT/ML Injection	SY	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
207390	50 ML Penicillin G Pot 20000 UNT/ML Injection	SY	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
204466	50 ML Penicillin G Pot 40000 UNT/ML Injection	SY	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
207391	50 ML Penicillin G Pot 60000 UNT/ML Injection	SY	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
207390	penicillin G potassium 1,000,000 UNT per 50 ML Injection	SY	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
204466	penicillin G potassium 2,000,000 UNT per 50 ML Injection	SY	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17
207391	penicillin G potassium 3,000,000 UNT per 50 ML Injection	SY	9e58122f-5c75-4905-a774-d3a4dae4ff8c	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-1021-41	00338102141	50 mL in 1 BAG (0338-1021-41)	50 ml	1990-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Penicillin G Potassium Injection, USP For Intravenous Use Only GALAXY Container	Baxter Healthcare Corporation	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	20