Folic Acid

Product NDC: 68788-8557
Requested package NDC: 68788-8557-6
11-digit product format: 687888557
Labeler code: 68788
Product ID: 68788-8557_a45f83d1-e6fa-4301-8868-e858d177f882
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Folic Acid
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA211064
Marketing category: ANDA
Marketing start: 2023-12-12
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211064-001	FOLIC ACID	FOLIC ACID	1MG	TABLET / ORAL	AA		2019-03-08

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA		2019-03-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A211064-001	AA	1	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Folic Acid	FOLIC ACID	Rising Pharma Holdings, Inc.	0baa10dd-6d1d-4946-8236-566451132da3	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	a1b71c5d-c842-43fd-9557-2bb4e934b914	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Preferred Pharmaceuticals Inc.	b4c3a754-64cd-499a-a32f-a6e935c41355	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064 ndc (package): 68788-8557-6 ndc (product): 68788-8557 ndc11 (package): 68788855706
Folic Acid	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	40ab3c91-5a5b-fa1d-e063-6394a90a7454	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	4889d474-bd72-46ba-81d6-5511d8a85abb	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	41914ac8-f4f5-4d70-b9f2-9f88c59d67a6	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	1383dce2-0b81-4694-a662-27576f867eae	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Method Pharmaceuticals, LLC	b9c315ff-cecb-8b75-e053-2995a90aa204	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	REMEDYREPACK INC.	bda4687e-929a-434d-ab59-909cf2ed73a2	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	NuCare Pharmaceuticals,Inc.	fa43f66c-9ae4-cd36-e053-6394a90a1526	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	fd0ec9f8-f547-4e5a-9847-a7ddfc3344bc	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	1b050122-73e9-48c7-9b26-431eaadddcfe	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	A-S Medication Solutions	16f8a1a1-ee81-4cd3-85e7-e1eae83fad67	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	A-S Medication Solutions	b48f4a4e-ece7-4bbb-b659-ed446cd9f0c9	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Proficient Rx LP	32203472-8724-4ba7-b0be-d834c3d7f074	2024-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	f8ffce0d-2b94-4a14-a08e-97646436cf6d	2023-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FOLIC ACID	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
935E97BOY8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310410	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b4c3a754-64cd-499a-a32f-a6e935c41355	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
91c62db0-0295-c81c-d10a-0856c259edd6	Product name	2	20200428
d32bc2b8-0bb7-2216-87aa-24639646e202	Product name	3	20190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-8557-1	Folic Acid	100 in 1 BOTTLE	TABLET	100	4
68788-8557-3	Folic Acid	30 in 1 BOTTLE	TABLET	30	4
68788-8557-6	Folic Acid	60 in 1 BOTTLE	TABLET	60	4
68788-8557-9	Folic Acid	90 in 1 BOTTLE	TABLET	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8557-1	EA - Each	68788-8557	900c8174-c358-4adf-93b0-72428e11e318	1	2024-04-05
68788-8557-3	EA - Each	68788-8557	adc72f62-06fc-4e7f-9a03-e3bb8e1ec031	1	2024-04-05
68788-8557-6	EA - Each	68788-8557	467af177-d5c8-4cda-9881-0733a3f3645d	1	2024-04-05
68788-8557-9	EA - Each	68788-8557	9ca30736-135b-4150-91ea-2b4ef885efcf	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8557	FOLIC ACID TABLET [PREFERRED PHARMACEUTICALS INC.]	2	Current NDC, 4 package rows	20240504_b4c3a754-64cd-499a-a32f-a6e935c41355.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
935E97BOY8	FOLIC ACID	59-30-3	FOLIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310410	folic acid 1 MG Oral Tablet	PSN	b4c3a754-64cd-499a-a32f-a6e935c41355	4
310410	folic acid 1 MG Oral Tablet	SCD	b4c3a754-64cd-499a-a32f-a6e935c41355	4
310410	folate 1 MG Oral Tablet	SY	b4c3a754-64cd-499a-a32f-a6e935c41355	4
310410	vitamin B9 1,000 MCG Oral Tablet	SY	b4c3a754-64cd-499a-a32f-a6e935c41355	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8557-6	68788855706	60 TABLET in 1 BOTTLE (68788-8557-6)	60 tablet	2023-12-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Folic Acid Tablets, USP	Preferred Pharmaceuticals Inc.	2026-04-22	HUMAN PRESCRIPTION DRUG LABEL	4