FOLIC ACID

Product NDC
53217-355
11-digit product format
532170355
Labeler code
53217
Product ID
53217-355_2db8c199-cb8f-4271-8743-2a32f566704c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
folic acid
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA204418
Marketing category
ANDA
Marketing start
2017-12-22
Marketing end
0000-00-00
Substance
FOLIC ACID
Active strength
1 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53217-355IInactivated by FDA2026-08-11
excluded packagepackage53217-35553217-355-90IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-355-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-355-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-355-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-355-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-355-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-355-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-355-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-355-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-355-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53217-355-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53217-355-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53217-355-90557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53217-355-908af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53217-355-90834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53217-355-901332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53217-355-90fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53217-355-9086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53217-355-90bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53217-355-908dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53217-355-90e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53217-355-909bebd1f3094a…5416666fcb17…

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
A204418-001FOLIC ACIDFOLIC ACID1MGTABLET / ORALAA2015-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204418-001AA

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 UTC2026-02A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-283f01610625f2…
2019-09-15 20:21 UTC2019-09A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204418-001FOLIC ACID1MGTABLET / ORALAA2015-07-28cb3db0bc1861…

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 UTC2026-02A204418-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204418-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204418-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204418-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204418-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204418-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204418-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204418-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204418-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204418-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204418-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204418-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204418-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204418-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204418-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204418-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204418-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204418-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204418-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204418-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204418-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A204418-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204418-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204418-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204418-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A204418-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204418-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204418-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204418-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204418-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204418-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204418-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204418-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204418-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204418-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204418-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204418-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204418-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204418-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204418-001AA1cb3db0bc1861…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-355-902020-01-31C16284748780-19d75b9d0-3694-f424-e053-dadaa90a57ceFolic Acid Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-355-90FOLIC ACID90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-355FOLIC ACID TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180817_fb349f2d-7982-4281-9f39-c3516c89feb6.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 ACIDCoupler LLC544e394d-3555-8ab1-e063-6394a90ade002026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204418
application number: ANDA204418
FOLIC ACIDFOLIC ACIDBryant Ranch Prepack93580111-3e70-4a87-8834-c7aa99ec75e32025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204418
application number: ANDA204418
FOLIC ACIDFOLIC ACIDPD-Rx Pharmaceuticals, Inc.726bb436-69e3-452f-9f28-153b58bf3ca52025-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204418
application number: ANDA204418
FOLIC ACIDFOLIC ACIDBryant Ranch Prepack0e7cb7ea-c94e-4ce6-8149-311dc9c94e032025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204418
application number: ANDA204418
Folic AcidFOLIC ACIDDIRECT RXbfcb0849-6d9b-7705-e053-2a95a90a65412025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204418
application number: ANDA204418
FOLIC ACIDFOLIC ACIDSUNRISE PHARMACEUTICAL, INC.6854412b-7ecb-4107-85eb-730f14e23f062024-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204418
application number: ANDA204418
FOLIC ACIDFOLIC ACIDA-S Medication Solutions21f7ccf1-1de6-4a6e-b017-2b85c9d62d132023-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204418
application number: ANDA204418
FOLIC ACIDFOLIC ACIDA-S Medication Solutionsa9583b76-822d-486a-947a-2be6356637d02023-05-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204418
application number: ANDA204418
FOLIC ACIDFOLIC ACIDAphena Pharma Solutions - Tennessee, LLCdc4d097d-6e7e-4229-9853-04c31444d7032022-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204418
application number: ANDA204418

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310410folic acid 1 MG Oral TabletPSNfb349f2d-7982-4281-9f39-c3516c89feb61
310410folic acid 1 MG Oral TabletSCDfb349f2d-7982-4281-9f39-c3516c89feb61
310410folate 1 MG Oral TabletSYfb349f2d-7982-4281-9f39-c3516c89feb61
310410vitamin B9 1,000 MCG Oral TabletSYfb349f2d-7982-4281-9f39-c3516c89feb61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-355-905321703559090 in 1 BOTTLEHistorical