Folic acid

Product NDC
71610-545
11-digit product format
716100545
Labeler code
71610
Product ID
71610-545_1ec4ab78-d5f1-4b20-a954-7cf965952c76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Folic Acid
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090035
Marketing category
ANDA
Marketing start
2019-05-30
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 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
A090035-001FOLIC ACIDFOLIC ACID1MGTABLET / ORALAA2009-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090035-001AA

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 · 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 UTC2026-02A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-093f01610625f2…
2019-09-15 20:21 UTC2019-09A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090035-001FOLIC ACID1MGTABLET / ORALAA2009-06-09cb3db0bc1861…

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 UTC2026-02A090035-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090035-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090035-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090035-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090035-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090035-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090035-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090035-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090035-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090035-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090035-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090035-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090035-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090035-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090035-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090035-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090035-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090035-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090035-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090035-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090035-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090035-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090035-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090035-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090035-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090035-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090035-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090035-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090035-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090035-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090035-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090035-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090035-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090035-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090035-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090035-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090035-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090035-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090035-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090035-001AA1cb3db0bc1861…

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
454f9fdc-fd8c-4838-8e5b-10f4c74110ddAvailable 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
71610-545-30Folic acid30 in 1 BOTTLETABLET301
71610-545-60Folic acid90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-545-30EA - Each71610-545307cab24-e2a8-4f20-8b41-6df45621b93612021-07-15
71610-545-60EA - Each71610-545e6edbd72-7616-43f7-a550-13e698228cb412021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-545FOLIC ACID TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20210525_454f9fdc-fd8c-4838-8e5b-10f4c74110dd.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
Folic acidFOLIC ACIDChartwell RX, LLC.9a533666-8906-438e-adf7-11bb162ecb632024-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090035
application number: ANDA090035
Folic acidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLC454f9fdc-fd8c-4838-8e5b-10f4c74110dd2021-05-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090035
application number: ANDA090035
ndc (product): 71610-545

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310410folic acid 1 MG Oral TabletPSN454f9fdc-fd8c-4838-8e5b-10f4c74110dd1
310410folic acid 1 MG Oral TabletSCD454f9fdc-fd8c-4838-8e5b-10f4c74110dd1
310410folate 1 MG Oral TabletSY454f9fdc-fd8c-4838-8e5b-10f4c74110dd1
310410vitamin B9 1,000 MCG Oral TabletSY454f9fdc-fd8c-4838-8e5b-10f4c74110dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-545-307161005453030 TABLET in 1 BOTTLE (71610-545-30) 30 tablet2021-04-300000-00-00NoNoCurrent
71610-545-607161005456090 TABLET in 1 BOTTLE (71610-545-60) 90 tablet2021-04-300000-00-00NoNoCurrent