Application 064082

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMPICILLIN TRIHYDRATE	AMPICILLIN/AMPICILLIN TRIHYDRATE	CAPSULE;ORAL	EQ 250MG BASE	No	No
002	AMPICILLIN TRIHYDRATE	AMPICILLIN/AMPICILLIN TRIHYDRATE	CAPSULE;ORAL	EQ 500MG BASE	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A064082-001	AMPICILLIN TRIHYDRATE	AMPICILLIN/AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29
A064082-002	AMPICILLIN TRIHYDRATE	AMPICILLIN/AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064082-002	AB

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL	AB		1995-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB		1995-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064082-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064082-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064082-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064082-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064082-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064082-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064082-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064082-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064082-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064082-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064082-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064082-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064082-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064082-002	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A064082-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064082-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A064082-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A064082-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064082-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A064082-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064082-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A064082-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064082-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064082-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064082-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064082-002	AB	1	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A064082-002	AB	1	`a50c72e98297…`

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	REMEDYREPACK INC.	4134cd79-c895-4e6e-b1d5-8e01c38bf2d1	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064082 application number: ANDA064082 ndc (product): 70518-2607
Ampicillin	AMPICILLIN	Sandoz Inc	0a66c5c3-63bf-46e3-835e-26b555ab6954	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064082 application number: ANDA064082 ndc (product): 0781-2145 ndc (product): 0781-2144

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-2144	Ampicillin	Ampicillin	Sandoz Inc	ANDA	Current
0781-2144	Ampicillin	Ampicillin	Sandoz Inc	ANDA	Current
0781-2144	Ampicillin	Ampicillin	Sandoz Inc	ANDA	Current
0781-2144	Ampicillin	Ampicillin	Sandoz Inc	ANDA	Current
0781-2145	Ampicillin	Ampicillin	Sandoz Inc	ANDA	Current
0781-2145	Ampicillin	Ampicillin	Sandoz Inc	ANDA	Current
0781-2145	Ampicillin	Ampicillin	Sandoz Inc	ANDA	Current
0781-2145	Ampicillin	Ampicillin	Sandoz Inc	ANDA	Current
68071-1981	Ampicillin	Ampicillin	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1981	Ampicillin	Ampicillin	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1981	Ampicillin	Ampicillin	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-7139	Ampicillin	Ampicillin	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1014	Ampicillin	Ampicillin	REMEDYREPACK INC.	ANDA	Current
70518-1014	Ampicillin	Ampicillin	REMEDYREPACK INC.	ANDA	Current
70518-2607	Ampicillin	Ampicillin	REMEDYREPACK INC.	ANDA	Current
70518-2607	Ampicillin	Ampicillin	REMEDYREPACK INC.	ANDA	Current
70518-2607	Ampicillin	Ampicillin	REMEDYREPACK INC.	ANDA	Current
70934-059	Ampicillin	Ampicillin	Denton Pharma, Inc.	ANDA	Current
70934-059	Ampicillin	Ampicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-059	Ampicillin	Ampicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-417	Ampicillin	Ampicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-417	Ampicillin	Ampicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-417	Ampicillin	Ampicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current