Folic Acid

Product NDC: 67046-1449
11-digit product format: 670461449
Labeler code: 67046
Product ID: 67046-1449_2d98f47c-49d0-628a-e063-6394a90af64f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Folic Acid
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA202437
Marketing category: ANDA
Marketing start: 2025-02-07
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 42.

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
A202437-001	FOLIC ACID	FOLIC ACID	1MG	TABLET / ORAL	AA		2014-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202437-001	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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202437-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2014-01-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202437-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202437-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202437-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202437-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202437-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202437-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202437-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202437-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202437-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202437-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202437-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202437-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202437-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202437-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202437-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202437-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202437-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202437-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202437-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202437-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202437-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202437-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202437-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202437-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202437-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202437-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202437-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202437-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202437-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202437-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202437-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202437-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202437-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202437-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202437-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202437-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202437-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202437-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202437-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202437-001	AA	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Folic Acid
Listing expiration: 2026-12-31

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
2d98f4c3-9b7a-f122-e063-6294a90a6a00	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	Strength	SPL version
67046-1449-3	Folic Acid	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1449	FOLIC ACID TABLET [COUPLER LLC]	1	Current NDC, 1 package rows	20250212_2d98f4c3-9b7a-f122-e063-6294a90a6a00.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Folic Acid	FOLIC ACID	REMEDYREPACK INC.	368b69a8-a021-47e3-a6d7-e3497d7363b1	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202437 application number: ANDA202437
Folic Acid	FOLIC ACID	Preferred Pharmaceuticals Inc.	a4fd896d-0a44-4e53-bbb0-d716765e58b1	2025-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202437 application number: ANDA202437
Folic Acid	FOLIC ACID	Coupler LLC	2d98f4c3-9b7a-f122-e063-6294a90a6a00	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202437 application number: ANDA202437 ndc (product): 67046-1449
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	ceedca87-e390-4123-8de5-8c2a28bd0377	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202437 application number: ANDA202437
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	f4ede23e-f091-46cb-b120-772ee71b8cb3	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202437 application number: ANDA202437
Folic Acid	FOLIC ACID	Modavar Pharmaceuticals LLC	0eea15e4-7e5d-44e9-818b-a0bdf5271c78	2023-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202437 application number: ANDA202437
Folic Acid	FOLIC ACID	Cadila Pharmaceuticals Limited	103c2cdd-5822-48ba-b62a-e2b11aa444ef	2023-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202437 application number: ANDA202437

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	2d98f4c3-9b7a-f122-e063-6294a90a6a00	1
310410	folic acid 1 MG Oral Tablet	SCD	2d98f4c3-9b7a-f122-e063-6294a90a6a00	1
310410	folate 1 MG Oral Tablet	SY	2d98f4c3-9b7a-f122-e063-6294a90a6a00	1
310410	vitamin B9 1,000 MCG Oral Tablet	SY	2d98f4c3-9b7a-f122-e063-6294a90a6a00	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1449-3	67046144903	30 TABLET in 1 BLISTER PACK (67046-1449-3)	30 tablet	2025-02-07	No	No	Current