Penicillin G Sodium

Product NDC: 0781-6153
11-digit product format: 007816153
Labeler code: 0781
Product ID: 0781-6153_0e84343e-8796-4c54-8dcc-8448a231fcfa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin G Sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Sandoz Inc
Application: ANDA065068
Marketing category: ANDA
Marketing start: 2001-02-26
Substance: PENICILLIN G SODIUM
Active strength: 5000000 [USP'U]/1
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	0781-6153	0781-6153-97	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065068-001	PENICILLIN G SODIUM	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS		RS	2001-02-26

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065068-001	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RS	2001-02-26	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PENICILLIN G SODIUM	5000000 [USP'U]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YS5LY7JF4N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
745302	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
23b6d4a3-b273-4e10-9da9-1376933fdbdf	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
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	SPL version
0781-6153-94	Penicillin G Sodium	1 in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1	15
0781-6153-95	Penicillin G Sodium	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10	15
0781-6153-97	Penicillin G Sodium	1 in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1	15
0781-6153-97	Penicillin G Sodium	50 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	50	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-6153-94	EA - Each	0781-6153	10b6ce8e-7539-4407-a3b1-f7c5176249c6	1	2012-07-24
0781-6153-95	EA - Each	0781-6153	5e5d1c94-31d1-4902-83e1-d182746eb5cf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PENICILLIN G SODIUM	ACTIVE INGREDIENT	YS5LY7JF4N	PENICILLIN G SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]	12
PENICILLIN G	ACTIVE MOIETY	Q42T66VG0C	PENICILLIN G SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-6153	PENICILLIN G SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]	15	Current NDC, Legacy NDC, 4 package rows	20200605_23b6d4a3-b273-4e10-9da9-1376933fdbdf.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 Sodium	PENICILLIN G SODIUM	Sandoz Inc	23b6d4a3-b273-4e10-9da9-1376933fdbdf	2020-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065068 application number: ANDA065068 ndc (product): 0781-6153

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YS5LY7JF4N	PENICILLIN G SODIUM	69-57-8	PENICILLIN G SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
745302	penicillin G sodium 100,000 UNT/ML Injectable Solution	PSN	23b6d4a3-b273-4e10-9da9-1376933fdbdf	15
745302	penicillin G sodium 100000 UNT/ML Injectable Solution	SCD	23b6d4a3-b273-4e10-9da9-1376933fdbdf	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-6153-94	00781615394	1 in 1 VIAL						Historical
0781-6153-95	00781615395	10 VIAL in 1 CARTON (0781-6153-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-6153-94)	10 vial	2001-02-26	0000-00-00	No	No	Current
0781-6153-97	00781615397	1 in 1 VIAL						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Penicillin G Sodium for Injection, USP 5,000,000 Units (5 million units)	Sandoz Inc	2020-05-27	HUMAN PRESCRIPTION DRUG LABEL	15