Junel Fe 1.5/30
- Product NDC
- 63187-890
- 11-digit product format
- 631870890
- Labeler code
- 63187
- Product ID
- 63187-890_d73ad261-b388-48ac-ad8f-133af829dfbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norethindrone acetate and ethinyl estradiol, and ferrous fumarate
- Dosage form
- KIT
- Labeler
- Proficient Rx LP
- Application
- ANDA076064
- Marketing category
- ANDA
- Marketing start
- 2003-09-18
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076064-001 | JUNEL FE 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076064-001 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | 2003-09-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | 2003-09-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | 2003-09-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | 2003-09-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | 2003-09-18 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | 2003-09-18 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | 2003-09-18 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | 2003-09-18 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | 2003-09-18 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | 2003-09-18 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | 2003-09-18 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | 2003-09-18 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | 2003-09-18 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A076064-001 | JUNEL FE 1.5/30 | 0.03MG;1.5MG | TABLET / ORAL-28 | AB | RS | 2003-09-18 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076064-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076064-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076064-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076064-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076064-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076064-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076064-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076064-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076064-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076064-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076064-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076064-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076064-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076064-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076064-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076064-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076064-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076064-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076064-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076064-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076064-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076064-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076064-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076064-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076064-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076064-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076064-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076064-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076064-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076064-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A076064-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A076064-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076064-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076064-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076064-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076064-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A076064-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A076064-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076064-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A076064-001 | AB | 1 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Junel Fe 1.5/30
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 253c6b2e-2c93-4ee7-94a6-fd063c569c1f | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63187-890-28 | Junel Fe 1.5/30 | 1 in 1 BLISTER PACK | KIT | 1 | 5 | |
| 63187-890-28 | Junel Fe 1.5/30 | 6 in 1 CARTON | KIT | 6 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63187-890-28 | EA - Each | 63187-890 | e0f9d224-fc21-4c21-99ad-2115ecbf4f29 | 1 | 2017-10-13 |
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 |
|---|---|---|---|---|---|---|
| JUNEL FE 28 DAY | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | A-S Medication Solutions | 0428e1fd-3e1b-44fe-83fe-cf6be0915552 | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | 076064 ANDA076064 |
| Junel 21 Day | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Teva Pharmaceuticals USA, Inc. | 8b82ad14-580c-4145-b825-dce849f95363 | 2025-02-27 | Boxed warning, Warnings, Adverse reactions | 076064 ANDA076064 |
| Loestrin Fe 28 Day | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | Teva Women's Health LLC | f29ebcb5-7e65-4092-bfaa-f5ec026fc255 | 2025-02-20 | Boxed warning, Warnings, Adverse reactions | 076064 ANDA076064 |
| Junel Fe 1.5/30 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE | Proficient Rx LP | 253c6b2e-2c93-4ee7-94a6-fd063c569c1f | 2022-12-01 | Boxed warning, Warnings, Adverse reactions | 076064 ANDA076064 63187-890 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1359025 | {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack [Junel Fe 1.5/30 28 Day] | BPCK | 253c6b2e-2c93-4ee7-94a6-fd063c569c1f | 5 |
| 1359023 | {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack | GPCK | 253c6b2e-2c93-4ee7-94a6-fd063c569c1f | 5 |
| 1359023 | Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack | PSN | 253c6b2e-2c93-4ee7-94a6-fd063c569c1f | 5 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | PSN | 253c6b2e-2c93-4ee7-94a6-fd063c569c1f | 5 |
| 1359025 | Junel Fe 1.5/30 28 Day Pack | PSN | 253c6b2e-2c93-4ee7-94a6-fd063c569c1f | 5 |
| 1359022 | norethindrone acetate 1.5 MG / ethinyl estradiol 30 MCG Oral Tablet | PSN | 253c6b2e-2c93-4ee7-94a6-fd063c569c1f | 5 |
| 1359022 | ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet | SCD | 253c6b2e-2c93-4ee7-94a6-fd063c569c1f | 5 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | SCD | 253c6b2e-2c93-4ee7-94a6-fd063c569c1f | 5 |
| 1359022 | ethinyl estradiol 30 MCG / norethindrone acetate 1.5 MG Oral Tablet | SY | 253c6b2e-2c93-4ee7-94a6-fd063c569c1f | 5 |
| 1359025 | Junel Fe 1.5/30 28 Day Pack | SY | 253c6b2e-2c93-4ee7-94a6-fd063c569c1f | 5 |
| 1359025 | Junel Fe 28 Day Pack | SY | 253c6b2e-2c93-4ee7-94a6-fd063c569c1f | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63187-890-28 | 63187089028 | 6 BLISTER PACK in 1 CARTON (63187-890-28) / 1 KIT in 1 BLISTER PACK | 6 blister pack | 2017-08-01 | 0000-00-00 | No | No | Current |