Application 218218

Type: ANDA
Sponsor: ASPIRO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	INJECTABLE;INJECTION	2.5MG/ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A218218-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP		2025-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218218-001	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.

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	A218218-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2025-11-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218218-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2025-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218218-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2025-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218218-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2025-11-13	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218218-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2025-11-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218218-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218218-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218218-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218218-001	AP	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218218-001	AP	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 3 of 5 · 93 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Golden State Medical Supply, Inc.	3283bba6-05dd-3766-e063-6394a90ada69	2025-04-11	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Chartwell RX, LLC	18f6d349-8c5c-4443-ac65-16bf6619ecdc	2025-03-25	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fe0583bf-9986-e01e-e053-6294a90a0b26	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fe05b8d8-fdee-903b-e053-6394a90a2e05	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	febce7aa-7f5a-e0c1-e053-6394a90aebc4	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Caplin Steriles Limited	e18cc04c-a808-4d92-9b66-762cd787abc5	2025-01-16	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	d23c757d-39f8-48c3-ba63-df2cbe58c516	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1076a3ef-de02-487f-8117-b4e80495db29	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: Verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fdb7cd57-d33c-f5a3-e053-6294a90aff31	2024-12-13	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	a9a1a522-231b-41a1-95c6-0c75dbb62f47	2024-12-06	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	c87c7f7e-cdf5-42c7-a831-a7515d2d51d6	2024-12-06	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Wilshire Pharmaceuticals, Inc.	5f665d08-e1e4-422a-88c2-d8834abf9e1a	2024-11-27	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Wilshire Pharmaceuticals, Inc.	f9399858-fd7a-4b73-8759-3e5bf3af2666	2024-11-27	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	FRESENIUS KABI USA, LLC	38ca9270-5538-467a-a3e9-c27968f3aafe	2024-11-08	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	660a83a9-60be-42d5-bc70-fe384e93beaa	2024-10-24	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	A-S Medication Solutions	0b00ec93-0bb3-4181-a6ef-45206f0621f7	2024-10-16	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3f14442c-8178-0bad-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a58f5f77-7e88-d622-e053-2a95a90a0d35	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	9055ed6b-f466-4f38-a9d9-f22e9ac97ad4	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	f88dfe56-08bc-46b1-8f05-f886a16a89bc	2024-07-08	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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