What is NDC 0641-0956?

0641-0956 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 50 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Promethazine Hydrochloride?

116 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Promethazine Hydrochloride NDC 0641-0956

NDC codes

FDA NDC Directory

Product NDC (as listed)0641-0956Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00641-0956Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0641-0956-25	0064109562500641095625	25 VIAL in 1 CARTON (0641-0956-25) / 1 mL in 1 VIAL (0641-0956-21)Marketed from Sep 19, 1973

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): Promethazine Hydrochloride
Generic name (nonproprietary): promethazine hydrochloride
Active ingredients: Promethazine hydrochloride — 50 mg/mL
Dosage form: Injection
Route: Intramuscular
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 083312
Marketing start: Sep 19, 1973
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 0641-0956_69363376-bd70-47d7-ad97-39b3772728faSPL ID 69363376-bd70-47d7-ad97-39b3772728faSPL set ID 365138a6-28d8-4881-a3e9-02c80aaf83e8RxCUI 992460, 992858UNII R61ZEH7I1I
Pharmacologic class: Phenothiazine

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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400641095625 followed by a unit qualifier and the quantity

Package 00641-0956-25. 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 Apr 10, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Promethazine hydrochloride injection is indicated for the following conditions: Amelioration of allergic reactions to blood or plasma. In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled. For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused. Active treatment of motion sickness. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. As an adjunct to analgesics for the control of postop…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0641-0956

What is NDC 0641-0956?: 0641-0956 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 50 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Promethazine Hydrochloride.
What is the active ingredient?: Promethazine hydrochloride.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Promethazine Hydrochloride?: 116 other product NDCs are listed under this name. See all Promethazine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Promethazine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Northwind Health Company, LLC	82868-115	82868-0115-20
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Coupler LLC	67046-1043	67046-1043-03
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-070	87441-0070-01
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1854	00121-1854-16
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-4419	70518-4419-00
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SyrupOral	Xttrium Laboratories, Inc.	0116-4023	00116-4023-16
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SyrupOral	Atlantic Biologicals Corp.	17856-4023	17856-4023-01
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/1	TabletOral	Coupler LLC	67046-1447	67046-1447-03
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	Kesin Pharma Corporation	81033-016	81033-0016-50
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Cardinal Health 107, LLC	55154-3373	55154-3373-00

All 117 Promethazine Hydrochloride NDCs

Other NDCs under ANDA 083312

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 083312
Product	Strength	Form · route	Labeler	Product NDC
Phenerganpromethazine hydrochloride	Promethazine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6082
Phenerganpromethazine hydrochloride	Promethazine hydrochloride 50 mg/mL	InjectionIntramuscular	Hikma Pharmaceuticals USA Inc.	0641-6083
Phenerganpromethazine hydrochloride	Promethazine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6084
Phenerganpromethazine hydrochloride	Promethazine hydrochloride 50 mg/mL	InjectionIntramuscular	Hikma Pharmaceuticals USA Inc.	0641-6085
Promethazine Hci	Promethazine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous	HF Acquisition Co. LLC, DBA HealthFirst	51662-1247
Promethazine Hci	Promethazine hydrochloride 50 mg/mL	InjectionIntramuscular, Intravenous	HF Acquisition Co. LLC, DBA HealthFirst	51662-1248
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9940
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9941
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/mL	InjectionIntramuscular	Henry Schein, Inc.	0404-9942
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-0928
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/mL	InjectionIntramuscular	Hikma Pharmaceuticals USA Inc.	0641-0929
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-0948
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/mL	InjectionIntramuscular	Hikma Pharmaceuticals USA Inc.	0641-0949
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-0955
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-1495
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/mL	InjectionIntramuscular	Hikma Pharmaceuticals USA Inc.	0641-1496
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6208
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/mL	InjectionIntramuscular	A-S Medication Solutions	50090-0879
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous	Cardinal Health 107, LLC	55154-2861
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous	Medical Purchasing Solutions, LLC	71872-7077

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