Ferrous Sulfate

Product NDC
57664-070
11-digit product format
576640070
Labeler code
57664
Product ID
57664-070_bca6e06f-e9ea-4957-af87-453044fbf10b
Type
HUMAN OTC DRUG
Nonproprietary name
Ferrous Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-07-01
Marketing end
0000-00-00
Substance
FERROUS SULFATE
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57664-070DDiscontinued by firm2026-08-17
excluded packagepackage57664-07057664-070-01DDiscontinued by firm2026-08-17
excluded packagepackage57664-07057664-070-10DDiscontinued by firm2026-08-17

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 1 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-070-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-070-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-070-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-070-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-070-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-070-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-070-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-070-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-070-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-070-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-070-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-070-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-070-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-070-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-070-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-070-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-070-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-070-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-070-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-070-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-070-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-070-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-070-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-070-10557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-070-01EA - Each57664-070f8f5b771-24d6-4924-93ef-1b14cbb0d89512015-01-05
57664-070-10EA - Each57664-070945c8086-99ad-448c-b3e1-02e5ec206a1912015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERROUS SULFATEACTIVE INGREDIENT39R4TAN1VTFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
FERROUS CATIONACTIVE MOIETYGW89581OWRFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
RIBOFLAVININACTIVE INGREDIENTTLM2976OFRFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFERROUS SULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletPSN6806aeb1-8f2e-af84-e053-2991aa0a0c7b3
310325ferrous sulfate 325 MG Oral TabletSCD6806aeb1-8f2e-af84-e053-2991aa0a0c7b3
310325ferrous sulfate 324 MG (iron 65 MG) Oral TabletSY6806aeb1-8f2e-af84-e053-2991aa0a0c7b3
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletSY6806aeb1-8f2e-af84-e053-2991aa0a0c7b3
310325FESO4 325 MG Oral TabletSY6806aeb1-8f2e-af84-e053-2991aa0a0c7b3
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletPSN567e3c88-f9e8-4421-aba6-1983faa5f15a2
310325ferrous sulfate 325 MG Oral TabletSCD567e3c88-f9e8-4421-aba6-1983faa5f15a2
310325ferrous sulfate 324 MG (iron 65 MG) Oral TabletSY567e3c88-f9e8-4421-aba6-1983faa5f15a2
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletSY567e3c88-f9e8-4421-aba6-1983faa5f15a2
310325FESO4 325 MG Oral TabletSY567e3c88-f9e8-4421-aba6-1983faa5f15a2