FERROUS SULFATE

Product NDC: 68210-1520
11-digit product format: 682101520
Labeler code: 68210
Product ID: 68210-1520_a71178c0-3156-4c4e-a189-357939a27e27
Type: HUMAN OTC DRUG
Nonproprietary name: FERROUS SULFATE, DRIED
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: SPIRIT PHARMACEUTICALS,LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2010-12-15
Marketing end: 0000-00-00
Substance: FERROUS SULFATE, DRIED
Active strength: 325 mg/1
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68210-1520		I	Inactivated by FDA	2026-10-12
excluded product	product	68210-1520		I	Inactivated by FDA	2026-10-12
excluded package	package	68210-1520	68210-1520-0	I	Inactivated by FDA	2026-10-12
excluded package	package	68210-1520	68210-1520-1	I	Inactivated by FDA	2026-10-12
excluded package	package	68210-1520	68210-1520-2	I	Inactivated by FDA	2026-10-12
excluded package	package	68210-1520	68210-1520-3	I	Inactivated by FDA	2026-10-12

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 3 · 132 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-1520-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-1520-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-1520-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-1520-2	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-1520-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-1520-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-1520-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-1520-2	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-1520-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-1520-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-1520-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-1520-2	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-1520-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-1520-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-1520-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-1520-2	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-1520-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-1520-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-1520-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-1520-2	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-1520-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-1520-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-1520-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-1520-2	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-1520-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-1520-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-1520-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-1520-2	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-1520-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-1520-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-1520-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-1520-2	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-1520-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-1520-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-1520-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-1520-2	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-1520-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-1520-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-1520-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-1520-2	`ad56d346431e…`	`cc804d4bbf1e…`

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
910c1bd7-67d1-44c7-ad4f-9445f827edcc	Product name	1	20230808

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
68210-1520-0	960f7f55-d358-8e05-e053-dbdaa90a074a	FERROUS SULFATE TABLETS USP 325 MG
68210-1520-1	960f7f55-c326-8e05-e053-dbdaa90a074a	FERROUS SULFATE TABLETS USP 325 MG
68210-1520-2	960f7f55-c326-8e05-e053-dbdaa90a074a	FERROUS SULFATE TABLETS USP 325 MG
68210-1520-3	960f7f55-c326-8e05-e053-dbdaa90a074a	FERROUS SULFATE TABLETS USP 325 MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68210-1520-0	FERROUS SULFATE	1 in 1 CARTON	TABLET, FILM COATED	1	1
68210-1520-0	FERROUS SULFATE	100 in 1 BOTTLE	TABLET, FILM COATED	100	1
68210-1520-1	FERROUS SULFATE	15000 in 1 BAG	TABLET, FILM COATED	15000	1
68210-1520-1	FERROUS SULFATE	1 in 1 DRUM	TABLET, FILM COATED	1	1
68210-1520-2	FERROUS SULFATE	10000 in 1 BAG	TABLET, FILM COATED	10000	1
68210-1520-2	FERROUS SULFATE	1 in 1 DRUM	TABLET, FILM COATED	1	1
68210-1520-3	FERROUS SULFATE	1 in 1 DRUM	TABLET, FILM COATED	1	1
68210-1520-3	FERROUS SULFATE	1000 in 1 BAG	TABLET, FILM COATED	1000	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FERROUS SULFATE, DRIED	ACTIVE INGREDIENT	RIB00980VW	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
FERROUS SULFATE, DRIED	ACTIVE INGREDIENT	RIB00980VW	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
IRON	ACTIVE MOIETY	E1UOL152H7	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
IRON	ACTIVE MOIETY	E1UOL152H7	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-1520	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1	Legacy NDC, 6 package rows	20101222_292ab31a-4857-4960-995d-e80f09106e28.zip
68210-1520	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1	Legacy NDC, 2 package rows	20110125_9fb466fe-9c2b-4014-9913-029348bda14c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310325	ferrous sulfate 325 MG (iron 65 MG) Oral Tablet	PSN	292ab31a-4857-4960-995d-e80f09106e28	1
310325	ferrous sulfate 325 MG (iron 65 MG) Oral Tablet	PSN	9fb466fe-9c2b-4014-9913-029348bda14c	1
310325	ferrous sulfate 325 MG Oral Tablet	SCD	292ab31a-4857-4960-995d-e80f09106e28	1
310325	ferrous sulfate 325 MG Oral Tablet	SCD	9fb466fe-9c2b-4014-9913-029348bda14c	1
310325	ferrous sulfate 324 MG (iron 65 MG) Oral Tablet	SY	292ab31a-4857-4960-995d-e80f09106e28	1
310325	ferrous sulfate 324 MG (iron 65 MG) Oral Tablet	SY	9fb466fe-9c2b-4014-9913-029348bda14c	1
310325	ferrous sulfate 325 MG (iron 65 MG) Oral Tablet	SY	292ab31a-4857-4960-995d-e80f09106e28	1
310325	ferrous sulfate 325 MG (iron 65 MG) Oral Tablet	SY	9fb466fe-9c2b-4014-9913-029348bda14c	1
310325	FESO4 325 MG Oral Tablet	SY	292ab31a-4857-4960-995d-e80f09106e28	1
310325	FESO4 325 MG Oral Tablet	SY	9fb466fe-9c2b-4014-9913-029348bda14c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68210-1520-0	68210152000	1 in 1 CARTON	Historical
68210-1520-1	68210152001	15000 in 1 BAG	Historical
68210-1520-2	68210152002	10000 in 1 BAG	Historical
68210-1520-3	68210152003	1 in 1 DRUM	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FERROUS SULFATE TABLETS USP 325 MG	SPIRIT PHARMACEUTICALS,LLC	2010-12-09	HUMAN OTC DRUG LABEL	1
FERROUS SULFATE TABLETS USP 325 MG	SPIRIT PHARMACEUTICALS,LLC	2010-12-09	HUMAN OTC DRUG LABEL	1