Ampicillin

Product NDC: 84549-113
11-digit product format: 845490113
Labeler code: 84549
Product ID: 84549-113_3a39177d-01e7-263c-e063-6394a90ae15b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ampicillin Sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: ProPharma Distribution
Application: ANDA065499
Marketing category: ANDA
Marketing start: 2012-02-01
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 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A065499-001	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION		2010-08-17
A065499-002	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17
A065499-003	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17
A065499-004	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17
A065499-005	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A065499-002	AP
A065499-003	AP
A065499-004	AP
A065499-005	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 6 · 205 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
2026-02-19 14:30 UTC	2026-02	A065499-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION		2010-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065499-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065499-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065499-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065499-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065499-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION		2010-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065499-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065499-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065499-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065499-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065499-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION		2010-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065499-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065499-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065499-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065499-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065499-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION		2010-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065499-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065499-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065499-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065499-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065499-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION		2010-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065499-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065499-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065499-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065499-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065499-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION		2010-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065499-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065499-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065499-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065499-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065499-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION		2010-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065499-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065499-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065499-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065499-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065499-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION		2010-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065499-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065499-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065499-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065499-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065499-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065499-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065499-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065499-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065499-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065499-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065499-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065499-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065499-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065499-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065499-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065499-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065499-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065499-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065499-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065499-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065499-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065499-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065499-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065499-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065499-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065499-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065499-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065499-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065499-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065499-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065499-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065499-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065499-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065499-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065499-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065499-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065499-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065499-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065499-004	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065499-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065499-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065499-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065499-004	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065499-005	AP	1	`d06236e962d9…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1721475	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
364b1db9-e523-7bae-e063-6294a90a651d	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
84549-113-10	Ampicillin	1 in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1		2

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMPICILLIN	AMPICILLIN SODIUM	Henry Schein, Inc.	06ca924c-5f3a-4924-90f4-5ba623daaa0e	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065499 application number: ANDA065499
Ampicillin	AMPICILLIN SODIUM	Eugia US LLC	b7bf2897-8272-4c7d-84e9-6fbba0ea63fa	2025-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065499 application number: ANDA065499
Ampicillin	AMPICILLIN SODIUM	ProPharma Distribution	364b1db9-e523-7bae-e063-6294a90a651d	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065499 application number: ANDA065499 ndc (product): 84549-113
AMPICILLIN	AMPICILLIN	HF Acquisition Co LLC, DBA HealthFirst	e51db6a3-027a-6e24-e053-2a95a90a1587	2024-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065499 application number: ANDA065499
Ampicillin	AMPICILLIN SODIUM	Medical Purchasing Solutions, LLC	690f1986-6da9-4787-e053-2a91aa0a2644	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065499 application number: ANDA065499
Ampicillin	AMPICILLIN SODIUM	Medical Purchasing Solutions, LLC	70c022b0-ac9a-409b-e053-2a91aa0a757e	2023-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065499 application number: ANDA065499

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
1721475	ampicillin 1 GM Injection	PSN	364b1db9-e523-7bae-e063-6294a90a651d	2
1721475	ampicillin 1000 MG Injection	SCD	364b1db9-e523-7bae-e063-6294a90a651d	2
1721475	ampicillin (as ampicillin sodium) 1 GM Injection	SY	364b1db9-e523-7bae-e063-6294a90a651d	2
1721475	ampicillin 1 GM Injection	SY	364b1db9-e523-7bae-e063-6294a90a651d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
84549-113-10	84549011310	1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (84549-113-10)	2025-08-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ampicillin for Injection, USP Rx Only (For Intramuscular or Intravenous Injection)	ProPharma Distribution	2025-07-18	HUMAN PRESCRIPTION DRUG LABEL	2