Ampicillin

Product NDC: 72485-421
11-digit product format: 724850421
Labeler code: 72485
Product ID: 72485-421_4596759f-66c6-5801-e063-6394a90a9879
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ampicillin
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Armas Pharmaceuticals Inc.
Application: ANDA201025
Marketing category: ANDA
Marketing start: 2023-11-10
Substance: AMPICILLIN SODIUM
Active strength: 1 g/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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A201025-001	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09
A201025-002	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09
A201025-003	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09
A201025-004	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201025-003	AP
A201025-004	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 5 · 172 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	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A201025-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201025-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201025-003	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201025-004	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201025-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201025-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201025-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201025-004	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201025-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201025-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201025-003	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201025-004	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201025-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201025-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201025-003	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201025-004	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201025-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201025-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201025-003	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201025-004	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201025-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201025-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201025-003	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201025-004	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201025-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201025-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201025-003	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201025-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201025-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201025-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201025-003	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201025-004	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201025-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201025-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201025-003	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201025-004	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201025-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201025-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201025-003	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201025-004	AP	1	`b00525d2431f…`

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: Ampicillin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMPICILLIN SODIUM	1 g/1

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1721475	Internal RxNorm lookup
1721476	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
34e95c91-3767-493c-8716-38e61e7c6674	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
72485-421-10	Ampicillin	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10		3
72485-421-10	Ampicillin	1 in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72485-421-10	EA - Each	72485-421	449f8ee2-0a35-4e17-a200-23da38a117d5	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72485-421	AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION AMPICILLIN INJECTION, POWDER, FOR SOLUTION [ARMAS PHARMACEUTICALS INC.]	2	Current NDC, 2 package rows	20231111_34e95c91-3767-493c-8716-38e61e7c6674.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	AMPICILLIN	ONESOURCE SPECIALTY PHARMA LIMITED	519f2131-79e7-569f-e063-6394a90a2f93	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025
Ampicillin sodium	AMPICILLIN SODIUM	Medical Purchasing Solutions, LLC	402e7cc7-5ae8-c113-e063-6394a90aa54a	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025
Ampicillin	AMPICILLIN	Armas Pharmaceuticals Inc.	34e95c91-3767-493c-8716-38e61e7c6674	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025 ndc (product): 72485-421
Ampicillin sodium	AMPICILLIN	Civica, Inc.	2fd0f9fa-5b86-42f7-9a9f-767123638d39	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025
Ampicillin	AMPICILLIN	Medical Purchasing Solutions, LLC	29675d9c-3248-337a-e063-6294a90a2e20	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JFN36L5S8K	AMPICILLIN SODIUM	69-52-3	AMPICILLIN SODIUM
7C782967RD	AMPICILLIN	69-53-4	Ampicillin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1721475	ampicillin 1 GM Injection	PSN	34e95c91-3767-493c-8716-38e61e7c6674	3
1721476	ampicillin 2 GM Injection	PSN	34e95c91-3767-493c-8716-38e61e7c6674	3
1721475	ampicillin 1000 MG Injection	SCD	34e95c91-3767-493c-8716-38e61e7c6674	3
1721476	ampicillin 2000 MG Injection	SCD	34e95c91-3767-493c-8716-38e61e7c6674	3
1721475	ampicillin (as ampicillin sodium) 1 GM Injection	SY	34e95c91-3767-493c-8716-38e61e7c6674	3
1721476	ampicillin (as ampicillin sodium) 2 GM Injection	SY	34e95c91-3767-493c-8716-38e61e7c6674	3
1721475	ampicillin 1 GM Injection	SY	34e95c91-3767-493c-8716-38e61e7c6674	3
1721476	ampicillin 2 GM Injection	SY	34e95c91-3767-493c-8716-38e61e7c6674	3
1721475	ampicillin 1 GM Injection	PSN	29675d9c-3248-337a-e063-6294a90a2e20	1
1721475	ampicillin 1000 MG Injection	SCD	29675d9c-3248-337a-e063-6294a90a2e20	1
1721475	ampicillin (as ampicillin sodium) 1 GM Injection	SY	29675d9c-3248-337a-e063-6294a90a2e20	1
1721475	ampicillin 1 GM Injection	SY	29675d9c-3248-337a-e063-6294a90a2e20	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72485-421-10	72485042110	10 VIAL in 1 CARTON (72485-421-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL	10 vial	2023-11-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ampicillin for Injection, USP (For Intramuscular or Intravenous Injection)	Armas Pharmaceuticals Inc. \| Onesource Specialty Pharma Limited - Beta Lactam Division	2025-07-31	HUMAN PRESCRIPTION DRUG LABEL	3
Ampicillin for Injection, USP	Medical Purchasing Solutions, LLC	2024-12-16	HUMAN PRESCRIPTION DRUG LABEL	1