What is NDC 76420-679?

76420-679 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 25 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. 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 76420-679

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-679Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0679Add 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
76420-679-01	7642006790176420067901	100 TABLET in 1 BOTTLE (76420-679-01)Marketed from Feb 26, 2024
76420-679-30	7642006793076420067930	30 TABLET in 1 BOTTLE (76420-679-30)Marketed from Feb 26, 2024
76420-679-60	7642006796076420067960	60 TABLET in 1 BOTTLE (76420-679-60)Marketed from Feb 26, 2024
76420-679-90	7642006799076420067990	90 TABLET in 1 BOTTLE (76420-679-90)Marketed from Feb 26, 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): Promethazine Hydrochloride
Generic name (nonproprietary): promethazine hydrochloride
Active ingredients: Promethazine hydrochloride — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040596
Marketing start: Dec 14, 2005
Listing expires: Dec 31, 2027
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 76420-679_1244caf6-4af2-dd22-e063-6294a90a81bdSPL ID 1244caf6-4af2-dd22-e063-6294a90a81bdSPL set ID b4985d9d-1aa0-4b36-bc98-6a5410ad9badRxCUI 992438, 992447, 992475UNII 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 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

N476420067901 followed by a unit qualifier and the quantity

Package 76420-0679-01. 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 Feb 26, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for co…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-679

What is NDC 76420-679?: 76420-679 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 25 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 4 package NDCs, 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?: Asclemed USA, Inc., NDC labeler code 76420. 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 040596

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

FDA NDC Directory listings under ANDA 040596
Product	Strength	Form · route	Labeler	Product NDC
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Northwind Health Company, LLC	82868-115
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/1	TabletOral	Coupler LLC	67046-1447
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Proficient Rx LP	71205-805
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-070
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	American Health Packaging	68084-155
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	A-S Medication Solutions	50090-4811
Promethazine Hydrochloride	Promethazine hydrochloride 12.5 mg/1	TabletOral	Asclemed USA, Inc.	76420-678
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	A-S Medication Solutions	50090-4812
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	A-S Medication Solutions	50090-4813
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/1	TabletOral	Asclemed USA, Inc.	76420-692
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	A-S Medication Solutions	50090-4875
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0265
Phenerganpromethazine hcl	Promethazine hydrochloride 12.5 mg/1	TabletOral	Direct_Rx	72189-402
Promethazine Hydrochloride	Promethazine hydrochloride 12.5 mg/1	TabletOral	American Health Packaging	60687-660
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-1306
Promethazine Hydrochloride	Promethazine hydrochloride 12.5 mg/1	TabletOral	Bryant Ranch Prepack	63629-1591
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Proficient Rx LP	71205-658
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4809
Promethazine Hydrochloride	Promethazine hydrochloride 12.5 mg/1	TabletOral	REMEDYREPACK INC.	70518-2488
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	BluePoint Laboratories	68001-162

Showing 20 of 39.