Progesterone
- Product NDC
- 70700-163
- 11-digit product format
- 707000163
- Labeler code
- 70700
- Product ID
- 70700-163_181873be-16cc-352d-9568-03af070a1fc1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Progesterone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Xiromed, LLC
- Application
- ANDA205229
- Marketing category
- ANDA
- Marketing start
- 2021-01-08
- Substance
- PROGESTERONE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Progesterone [CS], Progesterone [EPC]
- 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 |
|---|---|---|---|---|---|---|---|
| A205229-001 | PROGESTERONE | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | |
| A205229-002 | PROGESTERONE | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205229-001 | AB |
| A205229-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A205229-001 | PROGESTERONE | 100MG | CAPSULE / ORAL | AB | 2017-10-20 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A205229-002 | PROGESTERONE | 200MG | CAPSULE / ORAL | AB | 2017-10-20 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205229-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205229-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205229-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205229-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205229-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205229-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205229-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205229-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205229-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205229-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205229-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205229-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205229-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205229-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205229-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205229-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205229-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205229-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205229-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205229-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205229-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205229-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205229-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205229-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205229-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205229-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A205229-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A205229-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205229-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205229-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A205229-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A205229-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A205229-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A205229-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A205229-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205229-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A205229-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A205229-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A205229-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A205229-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Progesterone
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PROGESTERONE | 200 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4G7DS2Q64Y | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0bf317a8-96d6-849d-7850-9084205a5315 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b46148e2-ee15-98d5-12f0-f5ec8745f6fc | Product name | 3 | 20220927 |
| 76820076-f087-4073-b1d1-aa04b361335e | Product name | 2 | 20220921 |
| d3229c1a-4e51-4e04-9b13-00d24fd35242 | Product name | 1 | 20200821 |
| 213f0591-95c1-b398-40b7-08b31f66b026 | Product name | 4 | 20190206 |
| 85b2d644-53b2-f2dc-4dbc-859116ce56c0 | Product name | 1 | 20140508 |
| d048f0e3-3c40-8816-8c5c-0ca5cd189aac | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70700-163-01 | Progesterone | 100 in 1 BOTTLE | CAPSULE | 100 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70700-163-01 | EA - Each | 70700-163 | d0cf579c-e65d-4af7-b770-0a910264f0f7 | 1 | 2021-02-05 |
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 |
|---|---|---|---|---|---|---|
| Progesterone | PROGESTERONE | Redpharm Drug | 5743b2e4-093f-c59a-e063-6394a90aae2b | 2026-07-23 | Warnings, Adverse reactions | 205229 ANDA205229 |
| Progesterone | PROGESTERONE | Bryant Ranch Prepack | 1ba10f9d-6e91-4954-ac91-23adcf8805b0 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 205229 ANDA205229 |
| Progesterone | PROGESTERONE | Bryant Ranch Prepack | 74a7619a-8f74-4889-96f6-5bae478543e8 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 205229 ANDA205229 |
| Progesterone | PROGESTERONE | AvKARE | 1637ac18-3a37-f3d5-e063-6394a90af157 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 205229 ANDA205229 |
| Progesterone | PROGESTERONE | Northstar Rx LLC | 73229a76-8de3-4cea-886f-568f0b817fea | 2026-02-19 | Warnings, Adverse reactions | 205229 ANDA205229 |
| Progesterone | PROGESTERONE | Xiromed, LLC | 0bf317a8-96d6-849d-7850-9084205a5315 | 2026-02-17 | Warnings, Adverse reactions | 205229 ANDA205229 70700-163 |
| Progesterone | PROGESTERONE | Direct_Rx | 462ae686-7264-4852-e063-6294a90aae98 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 205229 ANDA205229 |
| Progesterone | PROGESTERONE | Preferred Pharmaceuticals Inc. | 67842863-209d-4724-9e67-8d0c6282bd1d | 2025-09-15 | Boxed warning, Warnings, Adverse reactions | 205229 ANDA205229 |
| PROGESTERONE | PROGESTERONE | Direct Rx | dc9e2088-e11e-7d32-e053-2a95a90a2995 | 2025-01-22 | Warnings | 205229 ANDA205229 |
| Progesterone | PROGESTERONE | Proficient Rx LP | 80a63b2b-96be-423d-abbd-13acc802f6da | 2024-06-01 | Boxed warning, Warnings, Adverse reactions | 205229 ANDA205229 |
| Progesterone | PROGESTERONE | A-S Medication Solutions | 96c59a1c-d562-46dd-868b-b2decdfef319 | 2023-11-28 | Boxed warning, Warnings, Adverse reactions | 205229 ANDA205229 |
| Progesterone | PROGESTERONE | Asclemed USA, Inc. | fd6b9861-04fc-42d8-90c8-021a69fe93e9 | 2023-07-06 | Boxed warning, Warnings, Adverse reactions | 205229 ANDA205229 |
| Progesterone | PROGESTERONE | A-S Medication Solutions | 5e0263c5-2cb6-4e02-b883-2c05492a6260 | 2023-05-15 | Boxed warning, Warnings, Adverse reactions | 205229 ANDA205229 |
| Progesterone | PROGESTERONE | Asclemed USA, Inc. | 4a741977-1dbb-41e7-a560-9ac02936f8b1 | 2022-09-15 | Boxed warning, Warnings, Adverse reactions | 205229 ANDA205229 |
| Progesterone | PROGESTERONE | Proficient Rx LP | e1546b35-cfa8-4808-9652-db1ba675a4e3 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | 205229 ANDA205229 |
| Progesterone | PROGESTERONE | Proficient Rx LP | 73e65b35-2266-48a3-98f8-521446a55c22 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 205229 ANDA205229 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70700-163-01 | 70700016301 | 100 CAPSULE in 1 BOTTLE (70700-163-01) | 100 capsule | 2021-01-08 | 0000-00-00 | No | No | Current |