Application 061395

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 125MG BASE/VIAL	No	Yes
002	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	No	Yes
003	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	Yes
004	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	Yes
005	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	No	Yes
006	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
A061395-001	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982
A061395-002	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982
A061395-003	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982
A061395-004	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982
A061395-005	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982
A061395-006	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A061395-001	AP
A061395-002	AP
A061395-003	AP
A061395-004	AP
A061395-005	AP
A061395-006	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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A061395-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061395-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061395-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061395-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061395-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061395-006	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A061395-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061395-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061395-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061395-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061395-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061395-006	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061395-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061395-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061395-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061395-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061395-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061395-006	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061395-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061395-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061395-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061395-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061395-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061395-006	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061395-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061395-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061395-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061395-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061395-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061395-006	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061395-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061395-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061395-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061395-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061395-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061395-006	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061395-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061395-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061395-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061395-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 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	A061395-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061395-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061395-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061395-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061395-005	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061395-006	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A061395-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061395-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061395-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061395-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061395-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061395-006	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061395-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061395-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061395-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061395-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061395-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061395-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061395-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061395-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061395-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061395-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061395-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061395-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061395-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061395-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061395-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061395-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061395-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061395-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061395-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061395-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061395-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061395-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061395-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061395-006	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061395-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061395-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061395-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061395-004	AP	1	`b8a1b40f171c…`

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 SODIUM	Sandoz Inc	64a04e8c-8f78-46b3-8f45-56ef225a4f74	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061395 application number: ANDA061395
Ampicillin	AMPICILLIN SODIUM	Sandoz Inc	c2908a44-1da4-4885-ae5a-23f69189d91a	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061395 application number: ANDA061395
Ampicillin	AMPICILLIN SODIUM	Sandoz Inc	b371e1a5-1fef-4df2-8940-c4fc02b9e2f0	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061395 application number: ANDA061395
Ampicillin	AMPICILLIN SODIUM	Sandoz Inc	5308ddfa-4a5b-4f7b-83ce-9d1b528e050d	2024-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061395 application number: ANDA061395 ndc (product): 0781-9409
Ampicillin	AMPICILLIN SODIUM	Sandoz Inc	6632a5bd-45f1-422f-80b0-46e5a628969a	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061395 application number: ANDA061395

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 107 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-9409	Ampicillin	Ampicillin Sodium	Sandoz Inc	ANDA	Current
0781-9409	Ampicillin	Ampicillin Sodium	Sandoz Inc	ANDA	Current
0781-9409	Ampicillin	Ampicillin Sodium	Sandoz Inc	ANDA	Current
26637-321	Ampicillin	Ampicillin sodium	Putney Inc	ANDA	Current
43858-110	Ampicillin	Ampicillin sodium	Sandoz GmbH	ANDA	Current
43858-111	Ampicillin	Ampicillin sodium	Sandoz GmbH	ANDA	Current
43858-112	Ampicillin	Ampicillin sodium	Sandoz GmbH	ANDA	Current
43858-113	Ampicillin	Ampicillin sodium	Sandoz GmbH	ANDA	Current
43858-114	Ampicillin	Ampicillin sodium	Sandoz GmbH	ANDA	Current
43858-115	Ampicillin	Ampicillin Sodium	Sandoz GmbH	ANDA	Current
50090-4552	Ampicillin	Ampicillin sodium	A-S Medication Solutions	ANDA	Current
50090-4552	Ampicillin	Ampicillin sodium	A-S Medication Solutions	ANDA	Current
63323-704	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-704	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-704	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-704	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-705	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-705	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-705	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-705	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-707	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-707	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-707	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-708	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-708	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-708	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-708	Ampicillin	Ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current