Cryselle
- Product NDC
- 50090-2183
- 11-digit product format
- 500902183
- Labeler code
- 50090
- Product ID
- 50090-2183_cbabd0f6-72ca-4dd5-8b3f-9f1ad7c41c2f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- A-S Medication Solutions
- Application
- ANDA075840
- Marketing category
- ANDA
- Marketing start
- 2002-07-24
- 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 |
|---|---|---|---|---|---|---|---|
| A075840-001 | CRYSELLE | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | |
| A075840-002 | CRYSELLE | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075840-001 | AB |
| A075840-002 | 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 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | RS | 2001-11-30 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2001-11-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2001-11-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075840-001 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-21 | AB | 2001-11-30 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075840-002 | CRYSELLE | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2001-11-30 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075840-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075840-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075840-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075840-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075840-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075840-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075840-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075840-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075840-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075840-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075840-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075840-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075840-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075840-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075840-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075840-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075840-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075840-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075840-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075840-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075840-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075840-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075840-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075840-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075840-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075840-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075840-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075840-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075840-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075840-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075840-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075840-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075840-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075840-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075840-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075840-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075840-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075840-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075840-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075840-002 | AB | 1 | 74a2ff9319b5… |
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
- Cryselle
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-02-07 | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
| 2023-01-30 | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
| 2020-02-14 | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
| 2020-01-31 | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-2183-0 | Cryselle | 1 in 1 KIT | KIT | 1 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2183-0 | EA - Each | 50090-2183 | f1d8550c-093a-4ab8-af66-8d8e094ded4f | 1 | 2019-02-13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-2183 | CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS] | 15 | Current NDC, Legacy NDC, 1 package rows | 20240511_fcf4f8ea-1eb3-4a43-87d2-16f93e904443.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cryselle | NORGESTREL AND ETHINYL ESTRADIOL | A-S Medication Solutions | f73ece43-6b5f-4abb-ba6d-4d62775f2f8e | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 075840 ANDA075840 |
| Cryselle | NORGESTREL AND ETHINYL ESTRADIOL | A-S Medication Solutions | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 2024-05-07 | Boxed warning, Warnings, Adverse reactions | 075840 ANDA075840 50090-2183 |
| Cryselle | NORGESTREL AND ETHINYL ESTRADIOL | Proficient Rx LP | 9c4fac8e-8744-4378-80af-7887de955a51 | 2023-05-01 | Boxed warning, Warnings, Adverse reactions | 075840 ANDA075840 |
| Cryselle | NORGESTREL AND ETHINYL ESTRADIOL | Teva Pharmaceuticals USA, Inc. | ee6be128-d494-4361-9a0d-341c0eee3587 | 2022-07-28 | Boxed warning, Warnings, Adverse reactions | 075840 ANDA075840 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 750265 | {21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28] | BPCK | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 749786 | {21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 750265 | Cryselle 28 Day Pack | PSN | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 749786 | eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 748797 | inert 1 MG Oral Tablet | PSN | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 311359 | norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 311359 | ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet | SCD | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 750265 | Cryselle 28 Day Pack | SY | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
| 311359 | ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral Tablet | SY | fcf4f8ea-1eb3-4a43-87d2-16f93e904443 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-2183-0 | 50090218300 | 1 KIT in 1 KIT (50090-2183-0) | 1 kit | 2015-10-26 | 0000-00-00 | No | No | Current |