Folic Acid

Product NDC
53746-361
11-digit product format
537460361
Labeler code
53746
Product ID
53746-361_299a16c1-9627-45e2-a30c-e0f07ae9399a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Folic Acid
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA040625
Marketing category
ANDA
Marketing start
2022-03-07
Substance
FOLIC ACID
Active strength
1 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
A040625-001FOLIC ACIDFOLIC ACID1MGTABLET / ORALAARS2005-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040625-001AA

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 06:07:402026-07A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-213f01610625f2…
2019-09-15 20:21 UTC2019-09A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040625-001FOLIC ACID1MGTABLET / ORALAARS2005-07-21e64feba35796…

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 06:07:402026-07A040625-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040625-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040625-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040625-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040625-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040625-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040625-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040625-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040625-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040625-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040625-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040625-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040625-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040625-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040625-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040625-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040625-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040625-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040625-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040625-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040625-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040625-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040625-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040625-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040625-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040625-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040625-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040625-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040625-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040625-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040625-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040625-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040625-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040625-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040625-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040625-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040625-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040625-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040625-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040625-001AA1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Folic Acid
Listing expiration
2027-12-31

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
fd85395e-6a0b-4072-a80b-36095c0c6dd6Available 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
53746-361-01Folic Acid100 in 1 BOTTLETABLET1004
53746-361-10Folic Acid1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-361-01EA - Each53746-36133d0b3eb-e079-4568-ba57-e8aeee6a204912022-05-04
53746-361-10EA - Each53746-361575b5de3-d3a9-483d-8812-2e6d638c954212022-04-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOLIC ACIDACTIVE INGREDIENT935E97BOY8FOLIC ACID (FOLIC ACID) TABLET [AVPAK]5
FOLIC ACIDACTIVE MOIETY935E97BOY8FOLIC ACID (FOLIC ACID) TABLET [AVPAK]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFOLIC ACID (FOLIC ACID) TABLET [AVPAK]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFOLIC ACID (FOLIC ACID) TABLET [AVPAK]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FOLIC ACID (FOLIC ACID) TABLET [AVPAK]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFOLIC ACID (FOLIC ACID) TABLET [AVPAK]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-361FOLIC ACID TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]3Current NDC, Legacy NDC, 2 package rows20250503_fd85395e-6a0b-4072-a80b-36095c0c6dd6.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Folic AcidFOLIC ACIDNorthwind Health Company, LLC03b0aee4-804a-de63-e063-6394a90a66352026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040625
application number: ANDA040625
Folic AcidFOLIC ACIDMajor Pharmaceuticals7778ac96-7817-455a-a177-22ecb276c67f2026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040625
application number: ANDA040625
Folic AcidFOLIC ACIDCardinal Health 107, LLC624469a1-ded9-453a-973e-c5a2f0602bb02026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040625
application number: ANDA040625
Folic AcidFOLIC ACIDCardinal Health 107, LLC6dd867fe-597e-4915-8baf-98a605bf93242026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040625
application number: ANDA040625
Folic AcidFOLIC ACIDAmneal Pharmaceuticals of New York LLCfd85395e-6a0b-4072-a80b-36095c0c6dd62026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040625
application number: ANDA040625
ndc (product): 53746-361
Folic AcidFOLIC ACIDAmerican Health Packagingfc6dc1e1-f63e-4239-a1eb-67525569f68c2025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040625
application number: ANDA040625
Folic AcidFOLIC ACIDNuCare Pharmaceuticals,Inc.065e403b-7ba8-b584-e063-6294a90a15ec2025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040625
application number: ANDA040625
Folic AcidFOLIC ACIDAmneal Pharmaceuticals LLCc8fe09f0-b32b-43e3-8de7-ed38593b33b42024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040625
application number: ANDA040625
Folic AcidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLCd6c7ac9b-f44a-4f10-9d1d-efbebd37c3132019-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040625
application number: ANDA040625

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310410folic acid 1 MG Oral TabletPSNfd85395e-6a0b-4072-a80b-36095c0c6dd64
310410folic acid 1 MG Oral TabletPSN7778ac96-7817-455a-a177-22ecb276c67f4
310410folic acid 1 MG Oral TabletSCDfd85395e-6a0b-4072-a80b-36095c0c6dd64
310410folic acid 1 MG Oral TabletSCD7778ac96-7817-455a-a177-22ecb276c67f4
310410folate 1 MG Oral TabletSYfd85395e-6a0b-4072-a80b-36095c0c6dd64
310410folate 1 MG Oral TabletSY7778ac96-7817-455a-a177-22ecb276c67f4
310410vitamin B9 1,000 MCG Oral TabletSYfd85395e-6a0b-4072-a80b-36095c0c6dd64
310410vitamin B9 1,000 MCG Oral TabletSY7778ac96-7817-455a-a177-22ecb276c67f4
310410folic acid 1 MG Oral TabletPSN7e3cf91e-5f2e-43ed-a7c6-65a78b7379203
310410folic acid 1 MG Oral TabletPSNfc6dc1e1-f63e-4239-a1eb-67525569f68c3
310410folic acid 1 MG Oral TabletSCD7e3cf91e-5f2e-43ed-a7c6-65a78b7379203
310410folic acid 1 MG Oral TabletSCDfc6dc1e1-f63e-4239-a1eb-67525569f68c3
310410folate 1 MG Oral TabletSY7e3cf91e-5f2e-43ed-a7c6-65a78b7379203
310410folate 1 MG Oral TabletSYfc6dc1e1-f63e-4239-a1eb-67525569f68c3
310410vitamin B9 1,000 MCG Oral TabletSY7e3cf91e-5f2e-43ed-a7c6-65a78b7379203
310410vitamin B9 1,000 MCG Oral TabletSYfc6dc1e1-f63e-4239-a1eb-67525569f68c3
310410folic acid 1 MG Oral TabletPSN065e403b-7ba8-b584-e063-6294a90a15ec2
310410folic acid 1 MG Oral TabletPSN03b0aee4-804a-de63-e063-6394a90a66352
310410folic acid 1 MG Oral TabletSCD065e403b-7ba8-b584-e063-6294a90a15ec2
310410folic acid 1 MG Oral TabletSCD03b0aee4-804a-de63-e063-6394a90a66352
310410folate 1 MG Oral TabletSY065e403b-7ba8-b584-e063-6294a90a15ec2
310410folate 1 MG Oral TabletSY03b0aee4-804a-de63-e063-6394a90a66352
310410vitamin B9 1,000 MCG Oral TabletSY065e403b-7ba8-b584-e063-6294a90a15ec2
310410vitamin B9 1,000 MCG Oral TabletSY03b0aee4-804a-de63-e063-6394a90a66352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-361-0153746036101100 TABLET in 1 BOTTLE (53746-361-01) 100 tablet2022-03-070000-00-00NoNoCurrent
53746-361-10537460361101000 TABLET in 1 BOTTLE (53746-361-10) 1000 tablet2022-03-070000-00-00NoNoCurrent