Prescription drug · NDA
Endometrin (Progesterone) NDC 55566-6500
Progesterone 100 mg/1 · Insert · Vaginal · Ferring Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55566-6500-3 | 5556665000355566650003 | 1 CARTON in 1 CARTON (55566-6500-3) / 21 BLISTER PACK in 1 CARTON (55566-6500-2) / 1 INSERT in 1 BLISTER PACK (55566-6500-1)Marketed from Jun 21, 2007 | |
| 55566-6500-8 | 5556665000855566650008 | 1 CARTON in 1 CARTON (55566-6500-8) / 21 BLISTER PACK in 1 CARTON (55566-6500-7) / 1 INSERT in 1 BLISTER PACK (55566-6500-4)Marketed from Jun 21, 2007 · Sample package |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Endometrin
- Generic name (nonproprietary)
- progesterone
- Active ingredients
- Progesterone — 100 mg/1
- Dosage form
- Insert
- Route
- Vaginal
- Labeler
- Ferring Pharmaceuticals Inc.NDC labeler code 55566
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022057
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone (Chemical structure)
- Identifiers
- Product ID 55566-6500_7ff9c412-250d-4db8-b425-51c200241848SPL ID 7ff9c412-250d-4db8-b425-51c200241848SPL set ID 2ba50fa9-b349-40cb-9a4b-1af8faa4ec09RxCUI 725094, 725098UNII 4G7DS2Q64Y
- Pharmacologic class
- Progesterone
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N455566650003followed by a unit qualifier and the quantityPackage 55566-6500-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ENDOMETRIN ® is indicated, as part of an Assisted Reproductive Technology (ART) treatment program, to support embryo implantation in infertile women less than 35 years of age by supplementation of corpus luteal function and to maintain pregnancy after implantation up to 10 weeks. ENDOMETRIN is a progesterone indicated, as part of an Assisted Reproductive Technology (ART) treatment program, to support embryo implantation in infertile women less than 35 years of age by supplementation of corpus luteal function and to maintain pregnancy after implantation up to 10 weeks.
Excerpt only. Read the full label for complete information.
About NDC 55566-6500
- What is NDC 55566-6500?
- 55566-6500 is the product NDC for Endometrin (progesterone), Progesterone 100 mg/1 insert, listed with the FDA by Ferring Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Endometrin (Progesterone).
- What is the active ingredient?
- Progesterone.
- Who is the labeler?
- Ferring Pharmaceuticals Inc., NDC labeler code 55566. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Endometrin?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 022057
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Progesterone | Progesterone 100 mg/1 | InsertVaginal | Sun Pharmaceutical Industries, Inc. | 70095-136 |