Prescription drug · NDA
Taytulla NDC 0023-5862
norethindrone acetate and ethinyl estradiol, and ferrous fumarate · Kit · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0023-5862-29 | 0002358622900023586229 | 1 BLISTER PACK in 1 CARTON (0023-5862-29) / 1 KIT in 1 BLISTER PACKMarketed from May 1, 2016 · Sample package | |
| 0023-5862-30 | 0002358623000023586230 | 5 CARTON in 1 TRAY (0023-5862-30) / 1 BLISTER PACK in 1 CARTON (0023-5862-28) / 1 KIT in 1 BLISTER PACKMarketed from May 1, 2016 | |
| 0023-5862-31 | 0002358623100023586231 | 6 CARTON in 1 TRAY (0023-5862-31) / 6 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACKMarketed from May 1, 2016 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Taytulla
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol, and ferrous fumarate
- Dosage form
- Kit
- Labeler
- Allergan, Inc.NDC labeler code 0023
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204426
- Marketing start
- Listing expires
- Identifiers
- Product ID 0023-5862_031c2733-dbb1-443e-a5ec-4ce36d995402SPL ID 031c2733-dbb1-443e-a5ec-4ce36d995402SPL set ID 2fa8e8dc-f7b0-429a-b554-0e3c4291c92cRxCUI 1421459, 1421460, 1421461, 1809905
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
N400023586229followed by a unit qualifier and the quantityPackage 00023-5862-29. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
1 INDICATION S AND USAGE TAYTULLA is indicated for use by females of reproductive age to prevent pregnancy [ see Clinical Studies (14) ] . The efficacy of TAYTULLA in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. TAYTULLA is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy ( 1 ) The efficacy of TAYTULLA in females of reproductive potential with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated ( 1 , 8.8 )
Excerpt only. Read the full label for complete information.
About NDC 0023-5862
- What is NDC 0023-5862?
- 0023-5862 is the product NDC for Taytulla kit, listed with the FDA by Allergan, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Taytulla (Norethindrone acetate and ethinyl estradiol, and ferrous fumarate).
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Taytulla?
- 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.