Folic Acid

Product NDC: 72189-199
11-digit product format: 721890199
Labeler code: 72189
Product ID: 72189-199_2be95d4a-3002-97e4-e063-6294a90a5f3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Folic Acid
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA204418
Marketing category: ANDA
Marketing start: 2021-04-12
Substance: FOLIC ACID
Active strength: 1 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	72189-199		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-199	72189-199-30	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A204418-001	FOLIC ACID	FOLIC ACID	1MG	TABLET / ORAL	AA		2015-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204418-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204418-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204418-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204418-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204418-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204418-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204418-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204418-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204418-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204418-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204418-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204418-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204418-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204418-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204418-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204418-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204418-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204418-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204418-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204418-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204418-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204418-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204418-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204418-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204418-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204418-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204418-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204418-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204418-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204418-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204418-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204418-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204418-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204418-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204418-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204418-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204418-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204418-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204418-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204418-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204418-001	AA	1	`cb3db0bc1861…`

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
bfcb0849-6d9b-7705-e053-2a95a90a6541	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
72189-199-30	Folic Acid	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-199-30	EA - Each	72189-199	5d7fcb6c-e1e1-464a-923e-4cbde86de2a2	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-199	FOLIC ACID TABLET [DIRECT RX]	2	Current NDC, Legacy NDC, 1 package rows	20250119_bfcb0849-6d9b-7705-e053-2a95a90a6541.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOLIC ACID	FOLIC ACID	Coupler LLC	544e394d-3555-8ab1-e063-6394a90ade00	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	Bryant Ranch Prepack	93580111-3e70-4a87-8834-c7aa99ec75e3	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	PD-Rx Pharmaceuticals, Inc.	726bb436-69e3-452f-9f28-153b58bf3ca5	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	Bryant Ranch Prepack	0e7cb7ea-c94e-4ce6-8149-311dc9c94e03	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
Folic Acid	FOLIC ACID	DIRECT RX	bfcb0849-6d9b-7705-e053-2a95a90a6541	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418 ndc (product): 72189-199
FOLIC ACID	FOLIC ACID	SUNRISE PHARMACEUTICAL, INC.	6854412b-7ecb-4107-85eb-730f14e23f06	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	A-S Medication Solutions	21f7ccf1-1de6-4a6e-b017-2b85c9d62d13	2023-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	A-S Medication Solutions	a9583b76-822d-486a-947a-2be6356637d0	2023-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	dc4d097d-6e7e-4229-9853-04c31444d703	2022-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418

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	bfcb0849-6d9b-7705-e053-2a95a90a6541	2
310410	folic acid 1 MG Oral Tablet	SCD	bfcb0849-6d9b-7705-e053-2a95a90a6541	2
310410	folate 1 MG Oral Tablet	SY	bfcb0849-6d9b-7705-e053-2a95a90a6541	2
310410	vitamin B9 1,000 MCG Oral Tablet	SY	bfcb0849-6d9b-7705-e053-2a95a90a6541	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-199-30	72189019930	30 TABLET in 1 BOTTLE (72189-199-30)	30 tablet	2021-04-12	0000-00-00	No	No	Current