HYDROXYUREA

Product NDC
0555-0882
11-digit product format
005550882
Labeler code
0555
Product ID
0555-0882_9d7feae3-66af-434e-b5dc-569e8ce56b80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyurea
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075143
Marketing category
ANDA
Marketing start
1998-10-19
Substance
HYDROXYUREA
Active strength
500 mg/1
Pharmacologic classes
Antimetabolite [EPC], Urea [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075143-001HYDROXYUREAHYDROXYUREA500MGCAPSULE / ORALAB1998-10-16
A075143-002HYDROXYUREAHYDROXYUREA250MGCAPSULE / ORAL2000-09-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075143-001AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075143-001HYDROXYUREA500MGCAPSULE / ORALAB1998-10-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075143-002HYDROXYUREA250MGCAPSULE / ORAL2000-09-21bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075143-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075143-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075143-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075143-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075143-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075143-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075143-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075143-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075143-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075143-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075143-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075143-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075143-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075143-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075143-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075143-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075143-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075143-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075143-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075143-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075143-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075143-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075143-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075143-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075143-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075143-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075143-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075143-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075143-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075143-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075143-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075143-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075143-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075143-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075143-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075143-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075143-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075143-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075143-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075143-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
HYDROXYUREA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYUREA500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X6Q56QN5QCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197797Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9514ae5-79ae-4cc2-9d7f-c8f7806d1694Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
9be3ebe6-89e5-4e2f-8781-a389e7eb49e7Product name120250129
f76fb619-09b6-d149-3287-3661f7bc38cdProduct name320250124
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
62a0eedf-9497-47af-bccf-d51b8b15b067Product name120180307
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-0882-02HYDROXYUREA100 in 1 BOTTLECAPSULE10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0882-02EA - Each0555-08826f1fc549-d5a5-4c38-9499-d4fdbdc5fd8712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYUREAACTIVE INGREDIENTX6Q56QN5QCHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
HYDROXYUREAACTIVE MOIETYX6Q56QN5QCHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9NHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74HYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYUREA CAPSULE [BARR LABORATORIES INC.]8
HYDROXYUREAACTIVE INGREDIENTX6Q56QN5QCHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
HYDROXYUREAACTIVE MOIETYX6Q56QN5QCHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9NHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
HYDROXYUREAACTIVE INGREDIENTX6Q56QN5QCHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYUREAACTIVE MOIETYX6Q56QN5QCHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9NHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74HYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYUREA CAPSULE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0882HYDROXYUREA CAPSULE [TEVA PHARMACEUTICALS USA, INC.]20Current NDC, Legacy NDC, 1 package rows20240802_b9514ae5-79ae-4cc2-9d7f-c8f7806d1694.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROXYUREAHYDROXYUREAAvKARE862583ff-6d5c-3f7d-e3bd-352fb04009282025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075143
application number: ANDA075143
HYDROXYUREAHYDROXYUREATeva Pharmaceuticals USA, Inc.b9514ae5-79ae-4cc2-9d7f-c8f7806d16942024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075143
application number: ANDA075143
ndc (product): 0555-0882

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197797hydroxyurea 500 MG Oral CapsulePSNb9514ae5-79ae-4cc2-9d7f-c8f7806d169420
197797hydroxyurea 500 MG Oral CapsuleSCDb9514ae5-79ae-4cc2-9d7f-c8f7806d169420
197797hydroxyurea 500 MG Oral CapsulePSN862583ff-6d5c-3f7d-e3bd-352fb040092810
197797hydroxyurea 500 MG Oral CapsuleSCD862583ff-6d5c-3f7d-e3bd-352fb040092810
197797hydroxyurea 500 MG Oral CapsulePSN7a2e2305-78bd-4077-96c6-59c5059201ab2
197797hydroxyurea 500 MG Oral CapsuleSCD7a2e2305-78bd-4077-96c6-59c5059201ab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0882-0200555088202100 CAPSULE in 1 BOTTLE (0555-0882-02) 100 capsule1998-10-190000-00-00NoNoCurrent