FDA.reportPublic FDA data

Folic Acid

Product NDC
68071-2992
Requested package NDC
68071-2992-1
11-digit product format
680712992
Labeler code
68071
Product ID
68071-2992_2d53e5de-628b-12e9-e063-6294a90a6792
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Folic Acid
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA211064
Marketing category
ANDA
Marketing start
2022-10-25
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
A211064-001FOLIC ACIDFOLIC ACID1MGTABLET / ORALAA2019-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211064-001AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A211064-001FOLIC ACID1MGTABLET / ORALAA2019-03-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211064-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Folic AcidFOLIC ACIDRising Pharma Holdings, Inc.0baa10dd-6d1d-4946-8236-566451132da32026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDBryant Ranch Prepacka1b71c5d-c842-43fd-9557-2bb4e934b9142026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDPreferred Pharmaceuticals Inc.b4c3a754-64cd-499a-a32f-a6e935c413552026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLC40ab3c91-5a5b-fa1d-e063-6394a90a74542025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDBryant Ranch Prepack4889d474-bd72-46ba-81d6-5511d8a85abb2025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDBryant Ranch Prepack41914ac8-f4f5-4d70-b9f2-9f88c59d67a62025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDBryant Ranch Prepack1383dce2-0b81-4694-a662-27576f867eae2025-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDMethod Pharmaceuticals, LLCb9c315ff-cecb-8b75-e053-2995a90aa2042025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDREMEDYREPACK INC.bda4687e-929a-434d-ab59-909cf2ed73a22025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDNuCare Pharmaceuticals,Inc.fa43f66c-9ae4-cd36-e053-6394a90a15262025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
ndc (package): 68071-2992-1
ndc (product): 68071-2992
ndc11 (package): 68071299201
Folic AcidFOLIC ACIDBryant Ranch Prepackfd0ec9f8-f547-4e5a-9847-a7ddfc3344bc2024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDBryant Ranch Prepack1b050122-73e9-48c7-9b26-431eaadddcfe2024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDA-S Medication Solutions16f8a1a1-ee81-4cd3-85e7-e1eae83fad672024-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDA-S Medication Solutionsb48f4a4e-ece7-4bbb-b659-ed446cd9f0c92024-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDProficient Rx LP32203472-8724-4ba7-b0be-d834c3d7f0742024-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064
Folic AcidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLCf8ffce0d-2b94-4a14-a08e-97646436cf6d2023-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211064
application number: ANDA211064

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
fa43f66c-9ae4-cd36-e053-6394a90a1526Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2992-12025-02-04C16284748780-12cef2736-6cef-d83d-e063-dadaa90ab31fFolic Acid Tablets, USP
68071-2992-12025-01-30C16284748780-12cef2736-6cef-d83d-e063-dadaa90ab31fFolic Acid Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2992-1Folic Acid100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2992FOLIC ACID TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250206_fa43f66c-9ae4-cd36-e053-6394a90a1526.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310410folic acid 1 MG Oral TabletPSNfa43f66c-9ae4-cd36-e053-6394a90a15262
310410folic acid 1 MG Oral TabletSCDfa43f66c-9ae4-cd36-e053-6394a90a15262
310410folate 1 MG Oral TabletSYfa43f66c-9ae4-cd36-e053-6394a90a15262
310410vitamin B9 1,000 MCG Oral TabletSYfa43f66c-9ae4-cd36-e053-6394a90a15262

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-2992-168071299201100 TABLET in 1 BOTTLE (68071-2992-1) 100 tablet2023-04-26NoNoCurrent