Prescription drug · ANDA
Doxepin NDC 72603-223
Doxepin hydrochloride 6 mg/1 · Tablet, Film coated · Oral · North Star Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-223-01 | 7260302230172603022301 | 30 TABLET, FILM COATED in 1 BOTTLE (72603-223-01)Marketed from Apr 1, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Doxepin
- Generic name (nonproprietary)
- doxepin
- Active ingredients
- Doxepin hydrochloride — 6 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- North Star Rx LLCNDC labeler code 72603
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202337
- Marketing start
- Listing expires
- Identifiers
- Product ID 72603-223_472f1364-17cc-0996-e063-6394a90aa786SPL ID 472f1364-17cc-0996-e063-6394a90aa786SPL set ID 12edd5c6-c863-b83a-e063-6294a90a2f36RxCUI 966787, 966793UNII 3U9A0FE9N5UPC 0372603222012, 0372603223019
- Pharmacologic class
- Tricyclic Antidepressant
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
N472603022301followed by a unit qualifier and the quantityPackage 72603-0223-01. 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)
Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration. Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. ( 1 , 14 )
Excerpt only. Read the full label for complete information.
About NDC 72603-223
- What is NDC 72603-223?
- 72603-223 is the product NDC for Doxepin, Doxepin hydrochloride 6 mg/1 tablet, film coated, listed with the FDA by North Star Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Doxepin.
- What is the active ingredient?
- Doxepin hydrochloride.
- Who is the labeler?
- North Star Rx LLC, NDC labeler code 72603. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Doxepin?
- 23 other product NDCs are listed under this name. See all Doxepin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Doxepin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Doxepin | Doxepin hydrochloride 3 mg/1 | TabletOral | NorthStar Rx LLC | 72603-919 | 72603-0919-01 |
| Doxepin | Doxepin hydrochloride 6 mg/1 | TabletOral | NorthStar Rx LLC | 72603-920 | 72603-0920-01 |
| Doxepin | Doxepin hydrochloride 3 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-844 | 59651-0844-30 |
| Doxepin | Doxepin hydrochloride 6 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-845 | 59651-0845-30 |
| Doxepindoxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4327 | 70518-4327-00 |
| Doxepin | Doxepin hydrochloride 3 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-280 | 27241-0280-30 |
| Doxepin | Doxepin hydrochloride 6 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-281 | 27241-0281-30 |
| doxepin | Doxepin hydrochloride 3 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1528 | 70771-1528-0070771-1528-0170771-1528-03+3 more |
| doxepin | Doxepin hydrochloride 6 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1529 | 70771-1529-0070771-1529-0170771-1529-03+3 more |
| doxepin | Doxepin hydrochloride 3 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-181 | 72578-0181-0172578-0181-0572578-0181-06+3 more |
Other NDCs under ANDA 202337
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 |
|---|---|---|---|---|
| Doxepin | Doxepin hydrochloride 6 mg/1 | Tablet, Film coatedOral | Archis Pharma LLC | 72819-162 |
| Doxepin | Doxepin hydrochloride 3 mg/1 | Tablet, Film coatedOral | North Star Rx LLC | 72603-222 |
| Doxepin | Doxepin hydrochloride 3 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-758 |
| Doxepin | Doxepin hydrochloride 6 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-764 |
| Doxepin | Doxepin hydrochloride 3 mg/1 | Tablet, Film coatedOral | Archis Pharma LLC | 72819-161 |