AMPICILLIN

Product NDC: 0404-9760
11-digit product format: 004049760
Labeler code: 0404
Product ID: 0404-9760_81830402-f12b-4f6a-8ffc-fd0fc59e3adb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ampicillin Sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: ANDA065499
Marketing category: ANDA
Marketing start: 2026-07-31
Substance: AMPICILLIN SODIUM
Active strength: 1 g/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 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 · 215 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	A065499-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION		2010-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065499-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065499-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065499-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065499-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065499-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION		2010-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065499-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065499-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065499-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065499-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-08-17	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065499-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065499-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065499-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065499-005	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065499-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065499-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065499-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065499-005	AP	1	`caaa826d4ba7…`
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…`

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: 2027-12-31

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
78988f6a-a73b-4d3b-9a76-d61a748c3c16	Available on FDA.report

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMPICILLIN	AMPICILLIN SODIUM	Henry Schein, Inc.	78988f6a-a73b-4d3b-9a76-d61a748c3c16	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065499 application number: ANDA065499 ndc (product): 0404-9760
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0404-9760-99	00404976099	1 VIAL in 1 BAG (0404-9760-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL	1 vial	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ampicillin for Injection, USP, For Intramuscular or Intravenous Injection	Henry Schein, Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	1