Prescription drug · ANDA
Doxepin (Doxepin hydrochloride) NDC 64380-204
Doxepin hydrochloride 6 mg/1 · Tablet · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-204-01 | 6438002040164380020401 | 30 TABLET in 1 BOTTLE, PLASTIC (64380-204-01)Marketed from Sep 12, 2022 | |
| 64380-204-02 | 6438002040264380020402 | 100 TABLET in 1 BOTTLE, PLASTIC (64380-204-02)Marketed from Sep 12, 2022 | |
| 64380-204-03 | 6438002040364380020403 | 500 TABLET in 1 BOTTLE, PLASTIC (64380-204-03)Marketed from Sep 12, 2022 |
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 hydrochloride
- Active ingredients
- Doxepin hydrochloride — 6 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Strides Pharma Science LimitedNDC labeler code 64380
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202510
- Marketing start
- Listing expires
- Identifiers
- Product ID 64380-204_b6b0f575-6e3a-4011-b33f-a051103058c2SPL ID b6b0f575-6e3a-4011-b33f-a051103058c2SPL set ID 399866d5-3fa6-46d0-9c62-492d5997bc4fRxCUI 966787, 966793UNII 3U9A0FE9N5
- 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
N464380020401followed by a unit qualifier and the quantityPackage 64380-0204-01. 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 64380-204
- What is NDC 64380-204?
- 64380-204 is the product NDC for Doxepin (doxepin hydrochloride), Doxepin hydrochloride 6 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Doxepin (Doxepin hydrochloride).
- What is the active ingredient?
- Doxepin hydrochloride.
- Who is the labeler?
- Strides Pharma Science Limited, NDC labeler code 64380. 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 202510
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 |
|---|---|---|---|---|
| Doxepindoxepin hydrochloride | Doxepin hydrochloride 3 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-203 |
| Doxepindoxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4327 |
| Doxepindoxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3177 |
| Doxepindoxepin hydrochloride | Doxepin hydrochloride 3 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2474 |
| Doxepindoxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2475 |