Prescription drug · NDA
Synthroid (Levothyroxine sodium) NDC 0074-3727
Levothyroxine sodium 137 ug/1 · Tablet · Oral · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-3727-19 | 00074372719 | 1000 TABLET in 1 BOTTLE (0074-3727-19)Marketed from Jul 24, 2002 | |
| 0074-3727-72 | 00074372772 | 2 BLISTER PACK in 1 CARTON (0074-3727-72) / 7 TABLET in 1 BLISTER PACKMarketed from Jul 24, 2002 · Sample package | |
| 0074-3727-90 | 00074372790 | 90 TABLET in 1 BOTTLE (0074-3727-90)Marketed from Jul 24, 2002 |
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)
- Synthroid
- Generic name (nonproprietary)
- levothyroxine sodium
- Active ingredients
- Levothyroxine sodium — 137 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AbbVie Inc.NDC labeler code 0074
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021402
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 0074-3727_b85ab7fa-ba96-43cd-b736-44b3924e644cSPL ID b85ab7fa-ba96-43cd-b736-44b3924e644cSPL set ID 1e11ad30-1041-4520-10b0-8f9d30d30fccRxCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, 966220, 966221, 966222, 966224, 966225, 966247, 966248, 966249, 966250, 966251, 966253, 966270, 966271, 966282UNII 9J765S329GUPC 0300747149902, 0300747068197, 0300744341194, 0300745182192, 0300747070190, 0300747069903, 0300749296192, 0300743727906, 0300747148905, 0300746624905
- Pharmacologic class
- l-Thyroxine
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400074372719followed by a unit qualifier and the quantityPackage 00074-3727-19. 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)
Hypothyroidism SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid -Stimulating Hormone, TSH) Suppression SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatmen…
Excerpt only. Read the full label for complete information.
About NDC 0074-3727
- What is NDC 0074-3727?
- 0074-3727 is the product NDC for Synthroid (levothyroxine sodium), Levothyroxine sodium 137 ug/1 tablet, listed with the FDA by AbbVie Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Synthroid (Levothyroxine Sodium).
- What is the active ingredient?
- Levothyroxine sodium.
- Who is the labeler?
- AbbVie Inc., NDC labeler code 0074. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Synthroid?
- 11 other product NDCs are listed under this name. See all Synthroid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Synthroid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Synthroidlevothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | AbbVie Inc. | 0074-4552 | 00074-4552-1100074-4552-1900074-4552-72+1 more |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | AbbVie Inc. | 0074-6594 | 00074-6594-1900074-6594-7200074-6594-90 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 75 ug/1 | TabletOral | AbbVie Inc. | 0074-5182 | 00074-5182-1100074-5182-1900074-5182-72+1 more |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 150 ug/1 | TabletOral | AbbVie Inc. | 0074-7069 | 00074-7069-1100074-7069-1900074-7069-72+1 more |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 300 ug/1 | TabletOral | AbbVie Inc. | 0074-7149 | 00074-7149-1900074-7149-90 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 100 ug/1 | TabletOral | AbbVie Inc. | 0074-6624 | 00074-6624-1100074-6624-1900074-6624-72+1 more |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 25 ug/1 | TabletOral | AbbVie Inc. | 0074-4341 | 00074-4341-1900074-4341-7200074-4341-90 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | AbbVie Inc. | 0074-9296 | 00074-9296-1900074-9296-7200074-9296-90 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 175 ug/1 | TabletOral | AbbVie Inc. | 0074-7070 | 00074-7070-1900074-7070-90 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 125 ug/1 | TabletOral | AbbVie Inc. | 0074-7068 | 00074-7068-1100074-7068-1900074-7068-72+1 more |
Other NDCs under NDA 021402
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 |
|---|---|---|---|---|
| Synthroidlevothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | AbbVie Inc. | 0074-4552 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | AbbVie Inc. | 0074-6594 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 75 ug/1 | TabletOral | AbbVie Inc. | 0074-5182 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 150 ug/1 | TabletOral | AbbVie Inc. | 0074-7069 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 300 ug/1 | TabletOral | AbbVie Inc. | 0074-7149 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 100 ug/1 | TabletOral | AbbVie Inc. | 0074-6624 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 25 ug/1 | TabletOral | AbbVie Inc. | 0074-4341 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | AbbVie Inc. | 0074-9296 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 175 ug/1 | TabletOral | AbbVie Inc. | 0074-7070 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 125 ug/1 | TabletOral | AbbVie Inc. | 0074-7068 |
| Synthroidlevothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | AbbVie Inc. | 0074-7148 |