Finasteride

Product NDC
16729-090
11-digit product format
167290090
Labeler code
16729
Product ID
16729-090_23a879ed-37ee-0f94-e063-6394a90a17a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare, Inc.
Application
ANDA090121
Marketing category
ANDA
Marketing start
2010-05-28
Substance
FINASTERIDE
Active strength
5 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090121-001FINASTERIDEFINASTERIDE5MGTABLET / ORALAB2010-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090121-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-233f01610625f2…
2019-09-15 20:21 UTC2019-09A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090121-001FINASTERIDE5MGTABLET / ORALAB2010-02-23cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090121-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090121-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090121-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090121-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090121-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090121-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090121-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090121-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090121-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090121-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090121-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090121-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090121-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090121-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090121-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090121-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090121-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090121-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090121-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090121-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090121-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090121-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090121-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090121-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090121-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090121-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090121-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090121-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090121-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090121-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090121-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090121-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090121-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090121-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090121-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090121-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090121-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090121-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090121-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090121-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FINASTERIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
57GNO57U7GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310346Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
adfb8f6b-a7bb-4ac2-b2aa-fec6d56630adAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
d00474ae-23eb-a8eb-bf56-520e590cc6dbProduct name220170406
0f90664c-9d0e-f046-dc6a-73563cd8347eProduct name220170405

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-090-01Finasteride100 in 1 BOTTLETABLET, FILM COATED1009
16729-090-10Finasteride30 in 1 BOTTLETABLET, FILM COATED309
16729-090-15Finasteride90 in 1 BOTTLETABLET, FILM COATED909
16729-090-16Finasteride500 in 1 BOTTLETABLET, FILM COATED5009
16729-090-17Finasteride1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-090-01EA - Each16729-0909a56cc69-d7ab-4885-8a61-710f0c4f177212012-07-24
16729-090-10EA - Each16729-09015d0fc3a-e7f3-4349-9e48-ce6aaa5e052912012-07-24
16729-090-15EA - Each16729-090ca6e32d8-7da5-4ad6-b87a-9c2e1f2e1f9d12012-07-24
16729-090-16EA - Each16729-090f2ac5e23-0c01-4325-9bca-f6e9ec63ff8d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEFINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP]1
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEFINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-090FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]9Current NDC, Legacy NDC, 5 package rows20241006_adfb8f6b-a7bb-4ac2-b2aa-fec6d56630ad.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FinasterideFINASTERIDEAtlantic Biologicals Corps29e59387-120c-4367-9f87-75cb53b6460d2025-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090121
application number: ANDA090121
FinasterideFINASTERIDEBryant Ranch Prepackef9c0b23-4736-4fb0-862c-c2a4d644e0d62024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090121
application number: ANDA090121
FinasterideFINASTERIDEAccord Healthcare, Inc.adfb8f6b-a7bb-4ac2-b2aa-fec6d56630ad2024-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090121
application number: ANDA090121
ndc (product): 16729-090
FinasterideFINASTERIDENuCare Pharmaceuticals,Inc.54c73290-bdc1-3453-e054-00144ff88e882024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090121
application number: ANDA090121
FinasterideFINASTERIDENuCare Pharmaceuticals,Inc.549aab5d-819a-1691-e054-00144ff88e882024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090121
application number: ANDA090121
FinasterideFINASTERIDEProficient Rx LPe9ea2f77-11c3-4dbf-bdc4-d1b0e74379902022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090121
application number: ANDA090121
FinasterideFINASTERIDEBryant Ranch Prepack88511bd5-624e-49d6-b80e-1f1d47314fb62020-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090121
application number: ANDA090121

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSNef9c0b23-4736-4fb0-862c-c2a4d644e0d69
310346finasteride 5 MG Oral TabletPSNadfb8f6b-a7bb-4ac2-b2aa-fec6d56630ad9
310346finasteride 5 MG Oral TabletSCDef9c0b23-4736-4fb0-862c-c2a4d644e0d69
310346finasteride 5 MG Oral TabletSCDadfb8f6b-a7bb-4ac2-b2aa-fec6d56630ad9
310346FIN5C 5 MG Oral TabletSYef9c0b23-4736-4fb0-862c-c2a4d644e0d69
310346FIN5C 5 MG Oral TabletSYadfb8f6b-a7bb-4ac2-b2aa-fec6d56630ad9
310346finasteride 5 MG Oral TabletPSN29e59387-120c-4367-9f87-75cb53b6460d6
310346finasteride 5 MG Oral TabletPSNe9ea2f77-11c3-4dbf-bdc4-d1b0e74379906
310346finasteride 5 MG Oral TabletSCD29e59387-120c-4367-9f87-75cb53b6460d6
310346finasteride 5 MG Oral TabletSCDe9ea2f77-11c3-4dbf-bdc4-d1b0e74379906
310346FIN5C 5 MG Oral TabletSYe9ea2f77-11c3-4dbf-bdc4-d1b0e74379906
310346FIN5C 5 MG Oral TabletSY29e59387-120c-4367-9f87-75cb53b6460d6
310346finasteride 5 MG Oral TabletPSN54c73290-bdc1-3453-e054-00144ff88e884
310346finasteride 5 MG Oral TabletPSN549aab5d-819a-1691-e054-00144ff88e884
310346finasteride 5 MG Oral TabletSCD54c73290-bdc1-3453-e054-00144ff88e884
310346finasteride 5 MG Oral TabletSCD549aab5d-819a-1691-e054-00144ff88e884
310346FIN5C 5 MG Oral TabletSY54c73290-bdc1-3453-e054-00144ff88e884
310346FIN5C 5 MG Oral TabletSY549aab5d-819a-1691-e054-00144ff88e884
310346finasteride 5 MG Oral TabletPSN88511bd5-624e-49d6-b80e-1f1d47314fb63
310346finasteride 5 MG Oral TabletSCD88511bd5-624e-49d6-b80e-1f1d47314fb63
310346FIN5C 5 MG Oral TabletSY88511bd5-624e-49d6-b80e-1f1d47314fb63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-090-0116729009001100 TABLET, FILM COATED in 1 BOTTLE (16729-090-01) 2010-08-240000-00-00NoNoCurrent
16729-090-101672900901030 TABLET, FILM COATED in 1 BOTTLE (16729-090-10) 2010-05-280000-00-00NoNoCurrent
16729-090-151672900901590 TABLET, FILM COATED in 1 BOTTLE (16729-090-15) 2010-06-080000-00-00NoNoCurrent
16729-090-1616729009016500 TABLET, FILM COATED in 1 BOTTLE (16729-090-16) 2011-11-150000-00-00NoNoCurrent
16729-090-17167290090171000 TABLET, FILM COATED in 1 BOTTLE (16729-090-17) 2016-08-230000-00-00NoNoCurrent