Norgestimate and Ethinyl Estradiol
- Product NDC
- 68462-565
- Requested package NDC
- 68462-565-29
- 11-digit product format
- 684620565
- Labeler code
- 68462
- Product ID
- 68462-565_fbb3fa97-10f6-482a-8d60-e67563ec2bfb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norgestimate and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA200494
- Marketing category
- ANDA
- Marketing start
- 2011-06-17
- 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 |
|---|---|---|---|---|---|---|---|
| A200494-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | AB | RS | 2011-06-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200494-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A200494-001 | NORGESTIMATE AND ETHINYL ESTRADIOL | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | AB | RS | 2011-06-17 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A200494-001 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Norgestimate and Ethinyl Estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | Glenmark Pharmaceuticals Inc., USA | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | 200494 ANDA200494 68462-565-29 68462-565 68462056529 |
| Norgestimate and Ethinyl Estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | A-S Medication Solutions | 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600 | 2023-03-28 | Boxed warning, Warnings, Adverse reactions | 200494 ANDA200494 |
| Norgestimate and Ethinyl Estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | Proficient Rx LP | 4a159dcd-8af4-4e59-8f46-7b0fe5c22807 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 200494 ANDA200494 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Norgestimate and Ethinyl Estradiol
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8b247e46-203e-4f5b-b5a7-cbd57341c735 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68462-565-29 | Norgestimate and Ethinyl Estradiol | 3 in 1 CARTON | KIT | 3 | 17 | |
| 68462-565-84 | Norgestimate and Ethinyl Estradiol | 1 in 1 BLISTER PACK | KIT | 1 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68462-565-29 | EA - Each | 68462-565 | ee40e381-3d5e-4572-b13c-8ebf29af1c6a | 1 | 2012-07-24 |
| 68462-565-84 | EA - Each | 68462-565 | 8c297e84-c2b0-420d-918c-dbbb9b079d45 | 1 | 2019-07-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 749860 | {21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 17 |
| 749784 | {7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 17 |
| 749784 | Eth estra-Norgestim 0.035-0.18 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.215 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.25 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 17 |
| 749860 | Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 17 |
| 748797 | inert 1 MG Oral Tablet | PSN | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 17 |
| 406396 | norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 17 |
| 687424 | norgestimate 0.215 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 17 |
| 240128 | norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 17 |
| 406396 | ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet | SCD | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 17 |
| 687424 | ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet | SCD | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 17 |
| 240128 | ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet | SCD | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 17 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 17 |
| 240128 | ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet | SY | 8b247e46-203e-4f5b-b5a7-cbd57341c735 | 17 |
| 749784 | {7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600 | 8 |
| 749784 | Eth estra-Norgestim 0.035-0.18 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.215 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.25 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600 | 8 |
| 748797 | inert 1 MG Oral Tablet | PSN | 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600 | 8 |
| 406396 | norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600 | 8 |
| 687424 | norgestimate 0.215 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600 | 8 |
| 240128 | norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600 | 8 |
| 406396 | ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet | SCD | 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600 | 8 |
| 687424 | ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet | SCD | 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600 | 8 |
| 240128 | ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet | SCD | 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600 | 8 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600 | 8 |
| 240128 | ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet | SY | 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600 | 8 |
| 749784 | {7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 4a159dcd-8af4-4e59-8f46-7b0fe5c22807 | 4 |
| 749784 | Eth estra-Norgestim 0.035-0.18 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.215 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.25 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 4a159dcd-8af4-4e59-8f46-7b0fe5c22807 | 4 |
| 748797 | inert 1 MG Oral Tablet | PSN | 4a159dcd-8af4-4e59-8f46-7b0fe5c22807 | 4 |
| 406396 | norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 4a159dcd-8af4-4e59-8f46-7b0fe5c22807 | 4 |
| 687424 | norgestimate 0.215 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 4a159dcd-8af4-4e59-8f46-7b0fe5c22807 | 4 |
| 240128 | norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 4a159dcd-8af4-4e59-8f46-7b0fe5c22807 | 4 |
| 406396 | ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet | SCD | 4a159dcd-8af4-4e59-8f46-7b0fe5c22807 | 4 |
| 687424 | ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet | SCD | 4a159dcd-8af4-4e59-8f46-7b0fe5c22807 | 4 |
| 240128 | ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet | SCD | 4a159dcd-8af4-4e59-8f46-7b0fe5c22807 | 4 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 4a159dcd-8af4-4e59-8f46-7b0fe5c22807 | 4 |
| 240128 | ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet | SY | 4a159dcd-8af4-4e59-8f46-7b0fe5c22807 | 4 |
| 749784 | {7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 02e5c9a1-6002-499e-abe2-8473a5854178 | 3 |
| 749784 | Eth estra-Norgestim 0.035-0.18 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.215 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.25 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 02e5c9a1-6002-499e-abe2-8473a5854178 | 3 |
| 748797 | inert 1 MG Oral Tablet | PSN | 02e5c9a1-6002-499e-abe2-8473a5854178 | 3 |
| 406396 | norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 02e5c9a1-6002-499e-abe2-8473a5854178 | 3 |
| 406396 | norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 63e95a36-47e5-4f62-b390-65937744f7f5 | 3 |
| 687424 | norgestimate 0.215 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 02e5c9a1-6002-499e-abe2-8473a5854178 | 3 |
| 240128 | norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 02e5c9a1-6002-499e-abe2-8473a5854178 | 3 |
| 406396 | ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet | SCD | 02e5c9a1-6002-499e-abe2-8473a5854178 | 3 |
| 406396 | ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet | SCD | 63e95a36-47e5-4f62-b390-65937744f7f5 | 3 |
| 687424 | ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet | SCD | 02e5c9a1-6002-499e-abe2-8473a5854178 | 3 |
| 240128 | ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet | SCD | 02e5c9a1-6002-499e-abe2-8473a5854178 | 3 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 02e5c9a1-6002-499e-abe2-8473a5854178 | 3 |
| 240128 | ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet | SY | 02e5c9a1-6002-499e-abe2-8473a5854178 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68462-565-29 | 68462056529 | 3 BLISTER PACK in 1 CARTON (68462-565-29) / 1 KIT in 1 BLISTER PACK (68462-565-84) | 3 blister pack | 2011-06-17 | 0000-00-00 | No | No | Current |