Ampicillin

Product NDC: 43858-123
11-digit product format: 438580123
Labeler code: 43858
Product ID: 43858-123_e9974d32-be0e-4800-acc2-bb0f56a0dd4f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ampicillin Sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Sandoz GmbH
Application: ANDA062738
Marketing category: ANDA
Marketing start: 1987-02-19
Marketing end: 0000-00-00
Substance: AMPICILLIN SODIUM
Active strength: 1 g/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062738-001	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS			1987-02-19
A062738-002	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS			1987-02-19

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS			1987-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS			1987-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS			1987-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS			1987-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS			1987-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS			1987-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062738-001	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062738-002	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	1987-02-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A062738-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062738-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062738-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062738-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062738-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062738-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062738-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062738-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062738-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062738-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062738-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062738-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062738-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062738-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062738-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062738-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062738-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062738-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062738-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062738-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062738-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062738-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062738-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062738-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062738-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062738-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062738-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062738-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062738-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062738-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062738-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062738-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062738-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062738-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062738-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062738-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062738-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062738-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062738-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A062738-002	AP	1	`5aa47cf7b7d7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ampicillin	AMPICILLIN SODIUM	Sandoz Inc	67dd2930-8482-4da5-b663-b751aff18c61	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062738 application number: ANDA062738
Ampicillin	AMPICILLIN SODIUM	Sandoz Inc	f77db491-31c4-4a7c-a114-0f3244c97090	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062738 application number: ANDA062738

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	Marketing start	Marketing end	Sample	Exclude flag	Status
43858-123-92	43858012392	10 VIAL, GLASS in 1 PACKAGE (43858-123-92) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS	2017-08-01	0000-00-00	No	No	Current

Ampicillin

Orange Book products#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#