misoprostol
- Product NDC
- 12634-502
- 11-digit product format
- 126340502
- Labeler code
- 12634
- Product ID
- 12634-502_477e9a4a-19a9-6846-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MISOPROSTOL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotheca Inc.
- Application
- NDA019268
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2009-12-27
- Marketing end
- 0000-00-00
- Substance
- MISOPROSTOL
- Active strength
- 200 ug/1
- Pharmacologic classes
- Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 73109aa8-3e7c-b7a0-fb29-6f84db91e7d9 | Product name | 3 | 20231221 |
| c4e1eedc-aca2-4551-8382-89144ed9d049 | Product name | 3 | 20220126 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12634-502-00 | misoprostol | 10 in 1 BOTTLE | TABLET | 10 | 6 | |
| 12634-502-01 | misoprostol | 100 in 1 BOTTLE | TABLET | 100 | 6 | |
| 12634-502-09 | misoprostol | 35 in 1 BOTTLE | TABLET | 35 | 6 | |
| 12634-502-12 | misoprostol | 120 in 1 BOTTLE | TABLET | 120 | 6 | |
| 12634-502-18 | misoprostol | 180 in 1 BOTTLE | TABLET | 180 | 6 | |
| 12634-502-40 | misoprostol | 40 in 1 BOTTLE | TABLET | 40 | 6 | |
| 12634-502-42 | misoprostol | 42 in 1 BOTTLE | TABLET | 42 | 6 | |
| 12634-502-45 | misoprostol | 45 in 1 BOTTLE | TABLET | 45 | 6 | |
| 12634-502-50 | misoprostol | 50 in 1 BOTTLE | TABLET | 50 | 6 | |
| 12634-502-52 | misoprostol | 12 in 1 BLISTER PACK | TABLET | 12 | 6 | |
| 12634-502-54 | misoprostol | 14 in 1 BLISTER PACK | TABLET | 14 | 6 | |
| 12634-502-57 | misoprostol | 20 in 1 BLISTER PACK | TABLET | 20 | 6 | |
| 12634-502-59 | misoprostol | 30 in 1 BLISTER PACK | TABLET | 30 | 6 | |
| 12634-502-60 | misoprostol | 60 in 1 BOTTLE | TABLET | 60 | 6 | |
| 12634-502-61 | misoprostol | 10 in 1 BLISTER PACK | TABLET | 10 | 6 | |
| 12634-502-63 | misoprostol | 3 in 1 BLISTER PACK | TABLET | 3 | 6 | |
| 12634-502-66 | misoprostol | 6 in 1 BLISTER PACK | TABLET | 6 | 6 | |
| 12634-502-67 | misoprostol | 7 in 1 BLISTER PACK | TABLET | 7 | 6 | |
| 12634-502-69 | misoprostol | 9 in 1 BLISTER PACK | TABLET | 9 | 6 | |
| 12634-502-71 | misoprostol | 30 in 1 BOTTLE | TABLET | 30 | 6 | |
| 12634-502-74 | misoprostol | 24 in 1 BOTTLE | TABLET | 24 | 6 | |
| 12634-502-78 | misoprostol | 28 in 1 BOTTLE | TABLET | 28 | 6 | |
| 12634-502-79 | misoprostol | 25 in 1 BOTTLE | TABLET | 25 | 6 | |
| 12634-502-80 | misoprostol | 20 in 1 BOTTLE | TABLET | 20 | 6 | |
| 12634-502-81 | misoprostol | 21 in 1 BOTTLE | TABLET | 21 | 6 | |
| 12634-502-82 | misoprostol | 12 in 1 BOTTLE | TABLET | 12 | 6 | |
| 12634-502-84 | misoprostol | 14 in 1 BOTTLE | TABLET | 14 | 6 | |
| 12634-502-85 | misoprostol | 15 in 1 BOTTLE | TABLET | 15 | 6 | |
| 12634-502-90 | misoprostol | 90 in 1 BOTTLE | TABLET | 90 | 6 | |
| 12634-502-91 | misoprostol | 1 in 1 BLISTER PACK | TABLET | 1 | 6 | |
| 12634-502-92 | misoprostol | 2 in 1 BOTTLE | TABLET | 2 | 6 | |
| 12634-502-93 | misoprostol | 3 in 1 BOTTLE | TABLET | 3 | 6 | |
| 12634-502-94 | misoprostol | 4 in 1 BOTTLE | TABLET | 4 | 6 | |
| 12634-502-95 | misoprostol | 5 in 1 BOTTLE | TABLET | 5 | 6 | |
| 12634-502-96 | misoprostol | 6 in 1 BOTTLE | TABLET | 6 | 6 | |
| 12634-502-97 | misoprostol | 7 in 1 BOTTLE | TABLET | 7 | 6 | |
| 12634-502-98 | misoprostol | 8 in 1 BOTTLE | TABLET | 8 | 6 | |
| 12634-502-99 | misoprostol | 9 in 1 BOTTLE | TABLET | 9 | 6 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MISOPROSTOL | ACTIVE INGREDIENT | 0E43V0BB57 | MISOPROSTOL TABLET [APOTHECA, INC.] | 2 | |
| MISOPROSTOL | ACTIVE MOIETY | 0E43V0BB57 | MISOPROSTOL TABLET [APOTHECA, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MISOPROSTOL TABLET [APOTHECA, INC.] | 2 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | MISOPROSTOL TABLET [APOTHECA, INC.] | 2 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | MISOPROSTOL TABLET [APOTHECA, INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | MISOPROSTOL TABLET [APOTHECA, INC.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 317128 | miSOPROStol 200 MCG Oral Tablet | PSN | f15b41bd-ed36-4908-aba5-f0a019b7a26e | 6 |
| 317128 | misoprostol 0.2 MG Oral Tablet | SCD | f15b41bd-ed36-4908-aba5-f0a019b7a26e | 6 |
| 317128 | misoprostol 200 MCG Oral Tablet | SY | f15b41bd-ed36-4908-aba5-f0a019b7a26e | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 12634-502-00 | 12634050200 | 10 TABLET in 1 BOTTLE (12634-502-00) | 10 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-01 | 12634050201 | 100 TABLET in 1 BOTTLE (12634-502-01) | 100 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-09 | 12634050209 | 35 TABLET in 1 BOTTLE (12634-502-09) | 35 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-12 | 12634050212 | 120 TABLET in 1 BOTTLE (12634-502-12) | 120 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-18 | 12634050218 | 180 TABLET in 1 BOTTLE (12634-502-18) | 180 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-40 | 12634050240 | 40 TABLET in 1 BOTTLE (12634-502-40) | 40 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-42 | 12634050242 | 42 TABLET in 1 BOTTLE (12634-502-42) | 42 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-45 | 12634050245 | 45 TABLET in 1 BOTTLE (12634-502-45) | 45 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-50 | 12634050250 | 50 TABLET in 1 BOTTLE (12634-502-50) | 50 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-52 | 12634050252 | 12 TABLET in 1 BLISTER PACK (12634-502-52) | 12 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-54 | 12634050254 | 14 TABLET in 1 BLISTER PACK (12634-502-54) | 14 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-57 | 12634050257 | 20 TABLET in 1 BLISTER PACK (12634-502-57) | 20 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-59 | 12634050259 | 30 TABLET in 1 BLISTER PACK (12634-502-59) | 30 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-60 | 12634050260 | 60 TABLET in 1 BOTTLE (12634-502-60) | 60 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-61 | 12634050261 | 10 TABLET in 1 BLISTER PACK (12634-502-61) | 10 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-63 | 12634050263 | 3 TABLET in 1 BLISTER PACK (12634-502-63) | 3 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-66 | 12634050266 | 6 TABLET in 1 BLISTER PACK (12634-502-66) | 6 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-67 | 12634050267 | 7 TABLET in 1 BLISTER PACK (12634-502-67) | 7 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-69 | 12634050269 | 9 TABLET in 1 BLISTER PACK (12634-502-69) | 9 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-71 | 12634050271 | 30 TABLET in 1 BOTTLE (12634-502-71) | 30 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-74 | 12634050274 | 24 TABLET in 1 BOTTLE (12634-502-74) | 24 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-78 | 12634050278 | 28 TABLET in 1 BOTTLE (12634-502-78) | 28 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-79 | 12634050279 | 25 TABLET in 1 BOTTLE (12634-502-79) | 25 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-80 | 12634050280 | 20 TABLET in 1 BOTTLE (12634-502-80) | 20 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-81 | 12634050281 | 21 TABLET in 1 BOTTLE (12634-502-81) | 21 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-82 | 12634050282 | 12 TABLET in 1 BOTTLE (12634-502-82) | 12 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-84 | 12634050284 | 14 TABLET in 1 BOTTLE (12634-502-84) | 14 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-85 | 12634050285 | 15 TABLET in 1 BOTTLE (12634-502-85) | 15 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-90 | 12634050290 | 90 TABLET in 1 BOTTLE (12634-502-90) | 90 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-91 | 12634050291 | 1 TABLET in 1 BLISTER PACK (12634-502-91) | 1 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-92 | 12634050292 | 2 TABLET in 1 BOTTLE (12634-502-92) | 2 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-93 | 12634050293 | 3 TABLET in 1 BOTTLE (12634-502-93) | 3 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-94 | 12634050294 | 4 TABLET in 1 BOTTLE (12634-502-94) | 4 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-95 | 12634050295 | 5 TABLET in 1 BOTTLE (12634-502-95) | 5 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-96 | 12634050296 | 6 TABLET in 1 BOTTLE (12634-502-96) | 6 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-97 | 12634050297 | 7 TABLET in 1 BOTTLE (12634-502-97) | 7 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-98 | 12634050298 | 8 TABLET in 1 BOTTLE (12634-502-98) | 8 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |
| 12634-502-99 | 12634050299 | 9 TABLET in 1 BOTTLE (12634-502-99) | 9 tablet | 2009-12-27 | 0000-00-00 | No | No | Current |