Fosinopril Sodium and Hydrochlorothiazide

Product NDC: 63304-403
11-digit product format: 633040403
Labeler code: 63304
Product ID: 63304-403_02e7b2aa-cc39-461b-b7b1-b0576b7c959e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosinopril Sodium and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Ranbaxy Pharmaceuticals Inc.
Application: ANDA076739
Marketing category: ANDA
Marketing start: 2004-12-20
Marketing end: 0000-00-00
Substance: FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Active strength: 10 mg/1; mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63304-403		I	Inactivated by FDA	2026-10-05
excluded package	package	63304-403	63304-403-01	I	Inactivated by FDA	2026-10-05
excluded package	package	63304-403	63304-403-10	I	Inactivated by FDA	2026-10-05
excluded package	package	63304-403	63304-403-30	I	Inactivated by FDA	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 88 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-403-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-403-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-403-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-403-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-403-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-403-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-403-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-403-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-403-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-403-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-403-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-403-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-403-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-403-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-403-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-403-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-403-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-403-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-403-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-403-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-403-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-403-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-403-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-403-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-403-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-403-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-403-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-403-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-403-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-403-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-403-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-403-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-403-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-403-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-403-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-403-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63304-403-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63304-403-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63304-403-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63304-403-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63304-403-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63304-403-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63304-403-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63304-403-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63304-403-10	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL			2004-12-17
A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL			2004-12-17

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076739-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2004-12-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076739-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2004-12-17	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
90aa3f6a-97f0-be7e-d25b-b26d56ae287e	Product name	3	20201015
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63304-403-01	2019-11-27	C162847	48780-1	9855e2a2-3318-60a7-e053-dbdaa90a05bd	Fosinopril Sodium and Hydrochlorothiazide Tablets, USP Rx only
63304-403-10	2019-11-27	C162847	48780-1	9855e2a2-3318-60a7-e053-dbdaa90a05bd	Fosinopril Sodium and Hydrochlorothiazide Tablets, USP Rx only
63304-403-30	2019-11-27	C162847	48780-1	9855e2a2-3318-60a7-e053-dbdaa90a05bd	Fosinopril Sodium and Hydrochlorothiazide Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63304-403-01	Fosinopril Sodium and Hydrochlorothiazide	100 in 1 BOTTLE	TABLET	100	4
63304-403-10	Fosinopril Sodium and Hydrochlorothiazide	1000 in 1 BOTTLE	TABLET	1000	4
63304-403-30	Fosinopril Sodium and Hydrochlorothiazide	30 in 1 BOTTLE	TABLET	30	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-403-01	EA - Each	63304-403	a0d49ab0-a08a-4c8c-9482-1701a5dccd12	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FOSINOPRIL SODIUM	ACTIVE INGREDIENT	NW2RTH6T2N	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]	4
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]	4
FOSINOPRILAT	ACTIVE MOIETY	S312EY6ZT8	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]	4
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-403	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]	4	Legacy NDC, 3 package rows	20140214_52ee65a7-ca1f-48fd-8fad-d72ea0dad4de.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NW2RTH6T2N	FOSINOPRIL SODIUM	88889-14-9	FOSINOPRIL SODIUM
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857166	fosinopril sodium 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	52ee65a7-ca1f-48fd-8fad-d72ea0dad4de	4
857174	fosinopril sodium 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	52ee65a7-ca1f-48fd-8fad-d72ea0dad4de	4
857166	fosinopril sodium 10 MG / hydrochlorothiazide 12.5 MG Oral Tablet	SCD	52ee65a7-ca1f-48fd-8fad-d72ea0dad4de	4
857174	fosinopril sodium 20 MG / hydrochlorothiazide 12.5 MG Oral Tablet	SCD	52ee65a7-ca1f-48fd-8fad-d72ea0dad4de	4
857166	FNP Sodium 10 MG / HCTZ 12.5 MG Oral Tablet	SY	52ee65a7-ca1f-48fd-8fad-d72ea0dad4de	4
857174	FNP Sodium 20 MG / HCTZ 12.5 MG Oral Tablet	SY	52ee65a7-ca1f-48fd-8fad-d72ea0dad4de	4
857166	fosinopril sodium 10 MG / HCTZ 12.5 MG Oral Tablet	SY	52ee65a7-ca1f-48fd-8fad-d72ea0dad4de	4
857174	fosinopril sodium 20 MG / HCTZ 12.5 MG Oral Tablet	SY	52ee65a7-ca1f-48fd-8fad-d72ea0dad4de	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63304-403-01	63304040301	100 in 1 BOTTLE	Historical
63304-403-10	63304040310	1000 in 1 BOTTLE	Historical
63304-403-30	63304040330	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fosinopril Sodium and Hydrochlorothiazide Tablets, USP Rx only	Ranbaxy Pharmaceuticals Inc. \| Ranbaxy Laboratories Ltd.	2013-11-10	HUMAN PRESCRIPTION DRUG LABEL	4