FOLIC ACID

Product NDC
69315-127
11-digit product format
693150127
Labeler code
69315
Product ID
69315-127_92322e52-3179-4738-8c8a-14fef62311d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FOLIC ACID
Dosage form
TABLET
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA040796
Marketing category
ANDA
Marketing start
2009-01-12
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
A040796-001FOLIC ACIDFOLIC ACID1MGTABLET / ORALAA2009-01-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040796-001AA

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 06:07:402026-07A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-123f01610625f2…
2019-09-15 20:21 UTC2019-09A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040796-001FOLIC ACID1MGTABLET / ORALAA2009-01-12e64feba35796…

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 06:07:402026-07A040796-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040796-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040796-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040796-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040796-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040796-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040796-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040796-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040796-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040796-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040796-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040796-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040796-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040796-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040796-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040796-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040796-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040796-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040796-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040796-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040796-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040796-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040796-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040796-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040796-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040796-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040796-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040796-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040796-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040796-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040796-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040796-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040796-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040796-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040796-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040796-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040796-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040796-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040796-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040796-001AA1e64feba35796…

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
1ba8c407-9613-4319-ac40-0a429cb0f3f4Available 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
69315-127-01FOLIC ACID100 in 1 BOTTLETABLET1006
69315-127-10FOLIC ACID1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-127-01EA - Each69315-127e32b5f86-51ab-43ac-8ae4-875fbd311b8512016-06-14
69315-127-10EA - Each69315-12734c21087-25bf-426e-aff2-2424dfb0e42f12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-127FOLIC ACID TABLET [LEADING PHARMA, LLC]6Current NDC, Legacy NDC, 2 package rows20190220_1ba8c407-9613-4319-ac40-0a429cb0f3f4.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
FOLIC ACIDFOLIC ACIDUnit Dose Solutions, Inc.54db8b21-87b9-5e0c-e063-6394a90ae8ea2026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040796
application number: ANDA040796
Folic AcidFOLIC ACIDNuCare Pharmaceuticals, Inc.3f14442c-81ad-0bad-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040796
application number: ANDA040796
FOLIC ACIDFOLIC ACIDNuCare Pharmaceuticals,Inc.7873790c-d722-cd9a-e053-2991aa0a23a32024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040796
application number: ANDA040796
FOLIC ACIDFOLIC ACIDAphena Pharma Solutions - Tennessee, LLC141bb721-cd20-5bba-e063-6394a90ab8fa2024-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040796
application number: ANDA040796
FOLIC ACIDFOLIC ACIDBryant Ranch Prepack0b263a1e-260b-4775-a76e-766add336f122023-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040796
application number: ANDA040796
FOLIC ACIDFOLIC ACIDProficient Rx LP607d23e8-21ef-4d73-88f1-990cf267d22e2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040796
application number: ANDA040796
FOLIC ACIDFOLIC ACIDLeading Pharma, LLC1ba8c407-9613-4319-ac40-0a429cb0f3f42019-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040796
application number: ANDA040796
ndc (product): 69315-127

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310410folic acid 1 MG Oral TabletPSN3f14442c-81ad-0bad-e054-00144ff8d46c6
310410folic acid 1 MG Oral TabletPSN1ba8c407-9613-4319-ac40-0a429cb0f3f46
310410folic acid 1 MG Oral TabletSCD3f14442c-81ad-0bad-e054-00144ff8d46c6
310410folic acid 1 MG Oral TabletSCD1ba8c407-9613-4319-ac40-0a429cb0f3f46
310410folate 1 MG Oral TabletSY3f14442c-81ad-0bad-e054-00144ff8d46c6
310410folate 1 MG Oral TabletSY1ba8c407-9613-4319-ac40-0a429cb0f3f46
310410vitamin B9 1,000 MCG Oral TabletSY3f14442c-81ad-0bad-e054-00144ff8d46c6
310410vitamin B9 1,000 MCG Oral TabletSY1ba8c407-9613-4319-ac40-0a429cb0f3f46
310410folic acid 1 MG Oral TabletPSN7873790c-d722-cd9a-e053-2991aa0a23a34
310410folic acid 1 MG Oral TabletPSN0b263a1e-260b-4775-a76e-766add336f124
310410folic acid 1 MG Oral TabletSCD7873790c-d722-cd9a-e053-2991aa0a23a34
310410folic acid 1 MG Oral TabletSCD0b263a1e-260b-4775-a76e-766add336f124
310410folate 1 MG Oral TabletSY7873790c-d722-cd9a-e053-2991aa0a23a34
310410folate 1 MG Oral TabletSY0b263a1e-260b-4775-a76e-766add336f124
310410vitamin B9 1,000 MCG Oral TabletSY0b263a1e-260b-4775-a76e-766add336f124
310410vitamin B9 1,000 MCG Oral TabletSY7873790c-d722-cd9a-e053-2991aa0a23a34
310410folic acid 1 MG Oral TabletPSN607d23e8-21ef-4d73-88f1-990cf267d22e2
310410folic acid 1 MG Oral TabletPSN56ccdc1c-4f85-4b3a-b04b-3f06f37f816a2
310410folic acid 1 MG Oral TabletSCD607d23e8-21ef-4d73-88f1-990cf267d22e2
310410folic acid 1 MG Oral TabletSCD56ccdc1c-4f85-4b3a-b04b-3f06f37f816a2
310410folate 1 MG Oral TabletSY607d23e8-21ef-4d73-88f1-990cf267d22e2
310410folate 1 MG Oral TabletSY56ccdc1c-4f85-4b3a-b04b-3f06f37f816a2
310410vitamin B9 1,000 MCG Oral TabletSY56ccdc1c-4f85-4b3a-b04b-3f06f37f816a2
310410vitamin B9 1,000 MCG Oral TabletSY607d23e8-21ef-4d73-88f1-990cf267d22e2
310410folic acid 1 MG Oral TabletPSN26aa8bca-f6ce-1002-e063-6394a90aeb271
310410folic acid 1 MG Oral TabletPSN141bb721-cd20-5bba-e063-6394a90ab8fa1
310410folic acid 1 MG Oral TabletSCD26aa8bca-f6ce-1002-e063-6394a90aeb271
310410folic acid 1 MG Oral TabletSCD141bb721-cd20-5bba-e063-6394a90ab8fa1
310410folate 1 MG Oral TabletSY141bb721-cd20-5bba-e063-6394a90ab8fa1
310410folate 1 MG Oral TabletSY26aa8bca-f6ce-1002-e063-6394a90aeb271
310410vitamin B9 1,000 MCG Oral TabletSY141bb721-cd20-5bba-e063-6394a90ab8fa1
310410vitamin B9 1,000 MCG Oral TabletSY26aa8bca-f6ce-1002-e063-6394a90aeb271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-127-0169315012701100 TABLET in 1 BOTTLE (69315-127-01) 100 tablet2018-02-210000-00-00NoNoCurrent
69315-127-10693150127101000 TABLET in 1 BOTTLE (69315-127-10) 1000 tablet2018-02-210000-00-00NoNoCurrent