FOLIC ACID

Product NDC
11534-165
11-digit product format
115340165
Labeler code
11534
Product ID
11534-165_5250e701-9f7a-42a8-bae9-95c4779f06aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
folic acid
Dosage form
TABLET
Route
ORAL
Labeler
SUNRISE PHARMACEUTICAL, INC.
Application
ANDA204418
Marketing category
ANDA
Marketing start
2015-08-04
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
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…

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
6854412b-7ecb-4107-85eb-730f14e23f06Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11534-165-01FOLIC ACID100 in 1 BOTTLETABLET1005
11534-165-03FOLIC ACID1000 in 1 BOTTLETABLET10005
11534-165-90FOLIC ACID90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11534-165-01EA - Each11534-165d6aba9c4-25d0-407b-a2ed-60b53de587a212016-01-13
11534-165-03EA - Each11534-16502582222-36b2-435a-bf02-c98b4698345112016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOLIC ACIDACTIVE INGREDIENT935E97BOY8FOLIC ACID TABLET [SUNRISE PHARMACEUTICAL, INC.]1
FOLIC ACIDACTIVE MOIETY935E97BOY8FOLIC ACID TABLET [SUNRISE PHARMACEUTICAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFOLIC ACID TABLET [SUNRISE PHARMACEUTICAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFOLIC ACID TABLET [SUNRISE PHARMACEUTICAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FOLIC ACID TABLET [SUNRISE PHARMACEUTICAL, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFOLIC ACID TABLET [SUNRISE PHARMACEUTICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11534-165FOLIC ACID TABLET [SUNRISE PHARMACEUTICAL, INC.]5Current NDC, Legacy NDC, 3 package rows20241206_6854412b-7ecb-4107-85eb-730f14e23f06.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
ndc (product): 11534-165
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 TabletPSN93580111-3e70-4a87-8834-c7aa99ec75e3100
310410folic acid 1 MG Oral TabletSCD93580111-3e70-4a87-8834-c7aa99ec75e3100
310410folate 1 MG Oral TabletSY93580111-3e70-4a87-8834-c7aa99ec75e3100
310410vitamin B9 1,000 MCG Oral TabletSY93580111-3e70-4a87-8834-c7aa99ec75e3100
310410folic acid 1 MG Oral TabletPSNa9583b76-822d-486a-947a-2be6356637d013
310410folic acid 1 MG Oral TabletPSN726bb436-69e3-452f-9f28-153b58bf3ca513
310410folic acid 1 MG Oral TabletSCDa9583b76-822d-486a-947a-2be6356637d013
310410folic acid 1 MG Oral TabletSCD726bb436-69e3-452f-9f28-153b58bf3ca513
310410folate 1 MG Oral TabletSYa9583b76-822d-486a-947a-2be6356637d013
310410folate 1 MG Oral TabletSY726bb436-69e3-452f-9f28-153b58bf3ca513
310410vitamin B9 1,000 MCG Oral TabletSYa9583b76-822d-486a-947a-2be6356637d013
310410vitamin B9 1,000 MCG Oral TabletSY726bb436-69e3-452f-9f28-153b58bf3ca513
310410folic acid 1 MG Oral TabletPSN0e7cb7ea-c94e-4ce6-8149-311dc9c94e036
310410folic acid 1 MG Oral TabletSCD0e7cb7ea-c94e-4ce6-8149-311dc9c94e036
310410folate 1 MG Oral TabletSY0e7cb7ea-c94e-4ce6-8149-311dc9c94e036
310410vitamin B9 1,000 MCG Oral TabletSY0e7cb7ea-c94e-4ce6-8149-311dc9c94e036
310410folic acid 1 MG Oral TabletPSN6854412b-7ecb-4107-85eb-730f14e23f065
310410folic acid 1 MG Oral TabletSCD6854412b-7ecb-4107-85eb-730f14e23f065
310410folate 1 MG Oral TabletSY6854412b-7ecb-4107-85eb-730f14e23f065
310410vitamin B9 1,000 MCG Oral TabletSY6854412b-7ecb-4107-85eb-730f14e23f065
310410folic acid 1 MG Oral TabletPSNbfcb0849-6d9b-7705-e053-2a95a90a65412
310410folic acid 1 MG Oral TabletSCDbfcb0849-6d9b-7705-e053-2a95a90a65412
310410folate 1 MG Oral TabletSYbfcb0849-6d9b-7705-e053-2a95a90a65412
310410vitamin B9 1,000 MCG Oral TabletSYbfcb0849-6d9b-7705-e053-2a95a90a65412
310410folic acid 1 MG Oral TabletPSNfb349f2d-7982-4281-9f39-c3516c89feb61
310410folic acid 1 MG Oral TabletPSN65080b61-73eb-53fb-e053-2a91aa0a74461
310410folic acid 1 MG Oral TabletPSN21f7ccf1-1de6-4a6e-b017-2b85c9d62d131
310410folic acid 1 MG Oral TabletPSNdc4d097d-6e7e-4229-9853-04c31444d7031
310410folic acid 1 MG Oral TabletSCD65080b61-73eb-53fb-e053-2a91aa0a74461
310410folic acid 1 MG Oral TabletSCDfb349f2d-7982-4281-9f39-c3516c89feb61
310410folic acid 1 MG Oral TabletSCDdc4d097d-6e7e-4229-9853-04c31444d7031
310410folic acid 1 MG Oral TabletSCD21f7ccf1-1de6-4a6e-b017-2b85c9d62d131
310410folate 1 MG Oral TabletSYdc4d097d-6e7e-4229-9853-04c31444d7031
310410folate 1 MG Oral TabletSY21f7ccf1-1de6-4a6e-b017-2b85c9d62d131
310410folate 1 MG Oral TabletSYfb349f2d-7982-4281-9f39-c3516c89feb61
310410folate 1 MG Oral TabletSY65080b61-73eb-53fb-e053-2a91aa0a74461
310410vitamin B9 1,000 MCG Oral TabletSYdc4d097d-6e7e-4229-9853-04c31444d7031
310410vitamin B9 1,000 MCG Oral TabletSY21f7ccf1-1de6-4a6e-b017-2b85c9d62d131
310410vitamin B9 1,000 MCG Oral TabletSY65080b61-73eb-53fb-e053-2a91aa0a74461
310410vitamin B9 1,000 MCG Oral TabletSYfb349f2d-7982-4281-9f39-c3516c89feb61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11534-165-0111534016501100 TABLET in 1 BOTTLE (11534-165-01) 100 tablet2015-08-040000-00-00NoNoCurrent
11534-165-03115340165031000 TABLET in 1 BOTTLE (11534-165-03) 1000 tablet2015-08-040000-00-00NoNoCurrent
11534-165-901153401659090 TABLET in 1 BOTTLE (11534-165-90) 90 tablet2017-09-290000-00-00NoNoCurrent