Application 070737

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDESOLUTION;INTRAVENOUS5MG/2ML (2.5MG/ML)NoYes
002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDESOLUTION;INTRAVENOUS10MG/4ML (2.5MG/ML)NoYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070737-001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06
A070737-002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A070737-001AP
A070737-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070737-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A070737-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAPRS1987-05-06782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A070737-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070737-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070737-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070737-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070737-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070737-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070737-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070737-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070737-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070737-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070737-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070737-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070737-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070737-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070737-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070737-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070737-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070737-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070737-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070737-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070737-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070737-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070737-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070737-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070737-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070737-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070737-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A070737-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070737-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070737-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070737-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A070737-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070737-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A070737-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070737-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A070737-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070737-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A070737-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070737-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A070737-002AP1782e0a99824c…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.1c993365-1b62-4524-e781-d307f28f63bc2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070737
application number: ANDA070737
ndc (product): 0409-1144
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.70057a53-ca29-4848-ab3d-5e691e2a14a32026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070737
application number: ANDA070737
ndc (product): 0409-1144
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst951c7fd7-10ef-2b07-e053-2995a90aaffd2024-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070737
application number: ANDA070737
ndc (product): 51662-1398
VERAPAMIL HCIVERAPAMIL HCIHF Acquisition Co LLC, DBA HealthFirst76112f5f-ce5d-ec60-e053-2a91aa0aae4e2024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070737
application number: ANDA070737
ndc (product): 51662-1269

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-1144Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1144Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1144Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1144Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1144Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1144Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1144Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1144Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1144Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.ANDACurrent
51662-1269VERAPAMIL HCIVERAPAMIL HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1269VERAPAMIL HCIVERAPAMIL HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1269VERAPAMIL HCIVERAPAMIL HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1269VERAPAMIL HCIVERAPAMIL HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1398VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1398VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1398VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1398VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-144Verapamil HydrochlorideVerapamil HydrochlorideGeneral Injectables & VacANDACurrent
52584-144Verapamil HydrochlorideVerapamil HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-144Verapamil HydrochlorideVerapamil HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-144Verapamil HydrochlorideVerapamil HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
55154-6982Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDECardinal HealthANDACurrent
55154-6982Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDECardinal HealthANDACurrent
55154-6990Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDECardinal HealthANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83447SUPPL 2025-09-25
83429SUPPL 2025-09-25