Folic Acid

Product NDC
0615-8589
11-digit product format
006158589
Labeler code
0615
Product ID
0615-8589_e309c4c9-fb32-4ee2-9588-0a7c1eb9edc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Folic Acid
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA091145
Marketing category
ANDA
Marketing start
2023-07-10
Substance
FOLIC ACID
Active strength
1 mg/1
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091145-001FOLIC ACIDFOLIC ACID1MGTABLET / ORALAA2013-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091145-001AA

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-123f01610625f2…
2019-09-15 20:21 UTC2019-09A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091145-001FOLIC ACID1MGTABLET / ORALAA2013-07-12e64feba35796…

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 06:07:402026-07A091145-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091145-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091145-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091145-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091145-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091145-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091145-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091145-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091145-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091145-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091145-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091145-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091145-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091145-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091145-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091145-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091145-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091145-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091145-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091145-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091145-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091145-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A091145-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091145-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091145-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091145-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A091145-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091145-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091145-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091145-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091145-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091145-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091145-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091145-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091145-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091145-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091145-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091145-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091145-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091145-001AA1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOLIC ACID1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
935E97BOY8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310410Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
76f51124-1e0f-499b-a6d1-7b4dbf313ca0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8589-05Folic Acid15 in 1 BLISTER PACKTABLET151
0615-8589-07Folic Acid7 in 1 BLISTER PACKTABLET71
0615-8589-39Folic Acid30 in 1 BLISTER PACKTABLET301

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Folic AcidFOLIC ACIDQUAGEN PHARMACEUTICALS LLC354366ea-3702-4706-9fc0-0244b7278bd82026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091145
application number: ANDA091145
Folic AcidFOLIC ACIDBryant Ranch Prepack3d3d6927-6138-485a-ad72-abd7ca167af72025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091145
application number: ANDA091145
Folic AcidFOLIC ACIDNCS HealthCare of KY, LLC dba Vangard Labs76f51124-1e0f-499b-a6d1-7b4dbf313ca02025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091145
application number: ANDA091145
ndc (product): 0615-8589

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310410folic acid 1 MG Oral TabletPSN76f51124-1e0f-499b-a6d1-7b4dbf313ca01
310410folic acid 1 MG Oral TabletSCD76f51124-1e0f-499b-a6d1-7b4dbf313ca01
310410folate 1 MG Oral TabletSY76f51124-1e0f-499b-a6d1-7b4dbf313ca01
310410vitamin B9 1,000 MCG Oral TabletSY76f51124-1e0f-499b-a6d1-7b4dbf313ca01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8589-050061585890515 TABLET in 1 BLISTER PACK (0615-8589-05) 15 tablet2025-09-12NoNoCurrent
0615-8589-07006158589077 TABLET in 1 BLISTER PACK (0615-8589-07) 7 tablet2025-09-12NoNoCurrent
0615-8589-390061585893930 TABLET in 1 BLISTER PACK (0615-8589-39) 30 tablet2025-09-12NoNoCurrent