National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2013-02-13
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 03:19:44
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43386-161-06 | EA - Each | 43386-161 | a5fb0ebd-625b-495c-9a23-cc83d8feb568 | 1 | 2013-02-13 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43386-161 | 43386-161-06 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091667-001 | MISOPROSTOL | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | ||
| A091667-002 | MISOPROSTOL | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 |
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 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | 2012-07-25 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | 2012-07-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | BX | 2012-07-25 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | BX | 2012-07-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | BX | 2012-07-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | BX | 2012-07-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | BX | 2012-07-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | BX | 2012-07-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091667-001 | MISOPROSTOL | 0.1MG | TABLET / ORAL | AB | 2012-07-25 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091667-002 | MISOPROSTOL | 0.2MG | TABLET / ORAL | AB | 2012-07-25 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091667-001 | BX | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091667-002 | BX | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091667-001 | BX | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091667-002 | BX | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091667-001 | BX | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091667-002 | BX | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091667-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091667-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091667-001 | BX | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091667-002 | BX | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091667-001 | BX | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091667-002 | BX | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091667-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091667-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A091667-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A091667-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A091667-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A091667-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A091667-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A091667-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A091667-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A091667-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091667-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A091667-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091667-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A091667-002 | AB | 1 | ea99ee380514… |
| 2023-01-26 05:58 UTC | 2023-01 | A091667-001 | BX | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A091667-002 | BX | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091667-001 | BX | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091667-002 | BX | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A091667-001 | BX | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A091667-002 | BX | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A091667-001 | BX | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A091667-002 | BX | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A091667-001 | BX | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A091667-002 | BX | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Misoprostol | MISOPROSTOL | Lupin Pharmaceuticals,Inc. | 14f73ae3-7d8d-4d10-b668-8bd5adf8032c | 2020-12-21 | Boxed warning, Warnings, Adverse reactions | 43386-161-06 43386016106 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.