Ampicillin

Product NDC: 72603-578
11-digit product format: 726030578
Labeler code: 72603
Product ID: 72603-578_ded2f0fe-8fdf-4ec1-ad0d-1f5ddc15cba5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ampicillin Sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: NorthStar Rx, LLC
Application: ANDA201404
Marketing category: ANDA
Marketing start: 2024-03-01
Substance: AMPICILLIN SODIUM
Active strength: 10 g/100mL
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 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
A201404-001	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2013-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201404-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201404-001	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-12-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201404-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201404-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201404-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201404-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201404-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201404-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201404-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201404-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201404-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201404-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201404-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201404-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201404-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201404-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201404-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201404-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201404-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201404-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201404-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201404-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201404-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201404-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201404-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201404-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201404-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201404-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201404-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201404-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201404-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201404-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201404-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201404-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201404-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201404-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201404-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201404-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201404-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201404-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201404-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201404-001	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ampicillin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMPICILLIN SODIUM	10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JFN36L5S8K	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3b683547-48ac-48ca-8fd4-6866fd17be34	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fd9d6ee0-43ae-43c7-aa52-3d5a936186d6	Product name	1	20250722
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3	Product name	2	20160201
c9385d77-2af7-47a4-bc97-1127e71caf9b	Product name	3	20160201
05b6b9ae-4ba4-27ee-4c8c-f72b41de3815	Product name	5	20151207
b353113e-7b3d-4b1f-a286-b96a3a5eac85	Product name	3	20151026
8c59be9b-72b0-49e8-b7ef-1a80c10599de	Product name	3	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72603-578-01	Ampicillin	100 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION, POWDER, FOR SOLUTION	100		1
72603-578-01	Ampicillin	10 in 1 BOX	INJECTION, POWDER, FOR SOLUTION	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72603-578-01	EA - Each	72603-578	cb2d7574-997a-4913-8eeb-a75908bf01ce	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72603-578	AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RX, LLC]	1	Current NDC, 2 package rows	20240301_3b683547-48ac-48ca-8fd4-6866fd17be34.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ampicillin Sodium	AMPICILLIN SODIUM	Sagent Pharmaceuticals	5b3796dd-6f81-4999-ae2b-a13a72795729	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201404 application number: ANDA201404
Ampicillin	AMPICILLIN	WG Critical Care, LLC	12b6ac82-ca74-4f88-99ea-ae4a1c419b70	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201404 application number: ANDA201404
Ampicillin	AMPICILLIN SODIUM	NorthStar Rx, LLC	3b683547-48ac-48ca-8fd4-6866fd17be34	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201404 application number: ANDA201404 ndc (product): 72603-578
Ampicillin	AMPICILLIN SODIUM	Avenacy Inc.	19546563-50b7-4160-8cbe-f8e7079cba69	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201404 application number: ANDA201404
Ampicillin	AMPICILLIN SODIUM	Athenex Pharmaceutical Division, LLC.	06b1c203-600c-4083-986a-d1d471b56e43	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201404 application number: ANDA201404

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JFN36L5S8K	AMPICILLIN SODIUM	69-52-3	AMPICILLIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
789980	ampicillin 100 MG/ML Injectable Solution	PSN	3b683547-48ac-48ca-8fd4-6866fd17be34	1
789980	ampicillin 100 MG/ML Injectable Solution	SCD	3b683547-48ac-48ca-8fd4-6866fd17be34	1
789980	ampicillin (as ampicillin sodium) 100 MG/ML Injectable Solution	SY	3b683547-48ac-48ca-8fd4-6866fd17be34	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72603-578-01	72603057801	10 VIAL, PHARMACY BULK PACKAGE in 1 BOX (72603-578-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE	2024-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ampicillin for Injection, USP PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Rx only	NorthStar Rx, LLC \| Istituto Biochimico Italiano Giovanni Lorenzini	2026-06-15	Human Prescription Drug Label	3