Prescription drug · ANDA
Hydroxyzine Hydrochloride NDC 68999-050
Hydroxyzine dihydrochloride 50 mg/25mL · Syrup · Oral · Chartwell Governmental & Specialty RX, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68999-050-24 | 6899900502468999005024 | 2 TRAY in 1 BOX (68999-050-24) / 10 CUP in 1 TRAY / 25 mL in 1 CUP (68999-050-52)Marketed from Oct 31, 2025 |
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)
- Hydroxyzine Hydrochloride
- Generic name (nonproprietary)
- hydroxyzine hydrochloride
- Active ingredients
- Hydroxyzine dihydrochloride — 50 mg/25mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- Chartwell Governmental & Specialty RX, LLC.NDC labeler code 68999
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 087294
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68999-050_4356ec2d-ecb8-1aed-e063-6394a90ad74eSPL ID 4356ec2d-ecb8-1aed-e063-6394a90ad74eSPL set ID 0de7a377-7a8f-4119-b172-1eadb4b7e1beRxCUI 995241UNII 76755771U3
- Pharmacologic class
- Antihistamine
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
N468999005024followed by a unit qualifier and the quantityPackage 68999-0050-24. 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)
INDICATIONS AND USAGE For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates , so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in…
Excerpt only. Read the full label for complete information.
About NDC 68999-050
- What is NDC 68999-050?
- 68999-050 is the product NDC for Hydroxyzine Hydrochloride, Hydroxyzine dihydrochloride 50 mg/25mL syrup, listed with the FDA by Chartwell Governmental & Specialty RX, LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydroxyzine Hydrochloride.
- What is the active ingredient?
- Hydroxyzine dihydrochloride.
- Who is the labeler?
- Chartwell Governmental & Specialty RX, LLC., NDC labeler code 68999. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydroxyzine Hydrochloride?
- 194 other product NDCs are listed under this name. See all Hydroxyzine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydroxyzine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydroxyzine Hydrochloride | Hydroxyzine hydrochloride 10 mg/5mL | SolutionOral | Advagen Pharma Limited | 72888-218 | 72888-0218-13 |
| Hydroxyzine hydrochloride | Hydroxyzine hydrochloride 50 mg/1 | TabletOral | Coupler LLC | 67046-0566 | 67046-0566-03 |
| Hydroxyzine hydrochloride | Hydroxyzine hydrochloride 10 mg/1 | TabletOral | Coupler LLC | 67046-0833 | 67046-0833-03 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0590 | 80425-0590-0180425-0590-0280425-0590-03 |
| Hydroxyzine hydrochloride | Hydroxyzine hydrochloride 50 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-039 | 87441-0039-01 |
| Hydroxyzine Hydrochloride | Hydroxyzine hydrochloride 10 mg/5mL | SolutionOral | Saptalis Pharmaceuticals, LLC. | 71656-090 | 71656-0090-16 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1311 | 67046-1311-03 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | TabletOral | Coupler LLC | 67046-0713 | 67046-0713-03 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 10 mg/5mL | SolutionOral | ANI Pharmaceuticals, Inc. | 70954-912 | 70954-0912-10 |
| Hydroxyzine Hydrochloride | Hydroxyzine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2148 | 55154-2148-00 |
Other NDCs under ANDA 087294
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 |
|---|---|---|---|---|
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/25mL | SyrupOral | Chartwell RX, LLC | 62135-050 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 10 mg/5mL | SyrupOral | Chartwell RX, LLC | 62135-750 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 10 mg/5mL | SyrupOral | Proficient Rx LP | 63187-494 |