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
Orange Book products#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | 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#
| 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 |
|---|---|
| FOLIC ACID | 1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 935E97BOY8 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 310410 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6854412b-7ecb-4107-85eb-730f14e23f06 | Available on FDA.report |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11534-165-01 | FOLIC ACID | 100 in 1 BOTTLE | TABLET | 100 | 5 | |
| 11534-165-03 | FOLIC ACID | 1000 in 1 BOTTLE | TABLET | 1000 | 5 | |
| 11534-165-90 | FOLIC ACID | 90 in 1 BOTTLE | TABLET | 90 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 11534-165-01 | EA - Each | 11534-165 | d6aba9c4-25d0-407b-a2ed-60b53de587a2 | 1 | 2016-01-13 |
| 11534-165-03 | EA - Each | 11534-165 | 02582222-36b2-435a-bf02-c98b46983451 | 1 | 2016-01-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | FOLIC ACID TABLET [SUNRISE PHARMACEUTICAL, INC.] | 1 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | FOLIC ACID TABLET [SUNRISE PHARMACEUTICAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FOLIC ACID TABLET [SUNRISE PHARMACEUTICAL, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FOLIC ACID TABLET [SUNRISE PHARMACEUTICAL, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | FOLIC ACID TABLET [SUNRISE PHARMACEUTICAL, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | FOLIC ACID TABLET [SUNRISE PHARMACEUTICAL, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
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.
| 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 | 204418 ANDA204418 |
| FOLIC ACID | FOLIC ACID | Bryant Ranch Prepack | 93580111-3e70-4a87-8834-c7aa99ec75e3 | 2025-10-21 | Warnings, Adverse reactions | 204418 ANDA204418 |
| FOLIC ACID | FOLIC ACID | PD-Rx Pharmaceuticals, Inc. | 726bb436-69e3-452f-9f28-153b58bf3ca5 | 2025-03-13 | Warnings, Adverse reactions | 204418 ANDA204418 |
| FOLIC ACID | FOLIC ACID | Bryant Ranch Prepack | 0e7cb7ea-c94e-4ce6-8149-311dc9c94e03 | 2025-01-28 | Warnings, Adverse reactions | 204418 ANDA204418 |
| Folic Acid | FOLIC ACID | DIRECT RX | bfcb0849-6d9b-7705-e053-2a95a90a6541 | 2025-01-17 | Warnings, Adverse reactions | 204418 ANDA204418 |
| FOLIC ACID | FOLIC ACID | SUNRISE PHARMACEUTICAL, INC. | 6854412b-7ecb-4107-85eb-730f14e23f06 | 2024-12-03 | Warnings, Adverse reactions | 204418 ANDA204418 11534-165 |
| FOLIC ACID | FOLIC ACID | A-S Medication Solutions | 21f7ccf1-1de6-4a6e-b017-2b85c9d62d13 | 2023-10-19 | Warnings, Adverse reactions | 204418 ANDA204418 |
| FOLIC ACID | FOLIC ACID | A-S Medication Solutions | a9583b76-822d-486a-947a-2be6356637d0 | 2023-05-09 | Warnings, Adverse reactions | 204418 ANDA204418 |
| FOLIC ACID | FOLIC ACID | Aphena Pharma Solutions - Tennessee, LLC | dc4d097d-6e7e-4229-9853-04c31444d703 | 2022-08-12 | Warnings, Adverse reactions | 204418 ANDA204418 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11534-165-01 | 11534016501 | 100 TABLET in 1 BOTTLE (11534-165-01) | 100 tablet | 2015-08-04 | 0000-00-00 | No | No | Current |
| 11534-165-03 | 11534016503 | 1000 TABLET in 1 BOTTLE (11534-165-03) | 1000 tablet | 2015-08-04 | 0000-00-00 | No | No | Current |
| 11534-165-90 | 11534016590 | 90 TABLET in 1 BOTTLE (11534-165-90) | 90 tablet | 2017-09-29 | 0000-00-00 | No | No | Current |