Follistim AQ
- Product NDC
- 0052-0313
- 11-digit product format
- 000520313
- Labeler code
- 0052
- Product ID
- 0052-0313_19e6b8fb-87e6-4dca-96c4-3cf8385533c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- follitropin
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Merck Sharp & Dohme LLC
- Application
- BLA021211
- Marketing category
- BLA
- Marketing start
- 2004-03-24
- Marketing end
- 0000-00-00
- Substance
- FOLLITROPIN
- Active strength
- 350 [iU]/.42mL
- Pharmacologic classes
- Gonadotropin [EPC], Gonadotropins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0052-0313-01 | 2021-09-17 | C162847 | 48780-1 | c7ccaba7-10f5-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 |
| 0052-0313-01 | 2021-09-17 | C162847 | 48780-1 | c7ccaba7-10f5-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 |
| 0052-0313-81 | 2021-09-17 | C162847 | 48780-1 | c7ccaba7-10f5-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 |
| 0052-0313-81 | 2021-09-17 | C162847 | 48780-1 | c7ccaba7-10f5-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 |
| 0052-0313-01 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-10f5-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 |
| 0052-0313-01 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-10f5-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 |
| 0052-0313-81 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-10f5-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 |
| 0052-0313-81 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-10f5-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| follitropin | ACTIVE INGREDIENT | 076WHW89TW | FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] | 13 | |
| follitropin | ACTIVE MOIETY | 076WHW89TW | FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] | 13 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] | 13 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] | 13 | |
| methionine | INACTIVE INGREDIENT | AE28F7PNPL | FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] | 13 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] | 13 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] | 13 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] | 13 | |
| trisodium citrate dihydrate | INACTIVE INGREDIENT | B22547B95K | FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] | 13 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0052-0313 | FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC] | 25 | Legacy NDC | 20241129_96f11b5d-cc7b-48aa-830a-a28e1962d871.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0052-0313-01 | 00052031301 | 1 KIT in 1 CARTON (0052-0313-01) > 1 CARTRIDGE in 1 KIT > .42 mL in 1 CARTRIDGE | 1 kit | 2004-03-24 | 0000-00-00 | No | No | Current |
| 0052-0313-81 | 00052031381 | 1 KIT in 1 CARTON (0052-0313-81) > 1 CARTRIDGE in 1 KIT > .42 mL in 1 CARTRIDGE | 1 kit | 2004-03-24 | 0000-00-00 | No | No | Current |