What is NDC 0121-1070?

0121-1070 is the product NDC for Promethazine DM, Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Dextromethorphan hydrobromide, Promethazine hydrochloride.

PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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 DM?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Promethazine DM NDC 0121-1070 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-1070Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-1070Add 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
0121-1070-04	0012110700400121107004	118 mL in 1 BOTTLE (0121-1070-04)Marketed from Jun 4, 2025
0121-1070-16	0012110701600121107016	473 mL in 1 BOTTLE (0121-1070-16)Marketed from Jun 4, 2025

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 DM
Generic name (nonproprietary): promethazine hydrochloride and dextromethorphan hydrobromide
Active ingredients: Dextromethorphan hydrobromide — 15 mg/5mLPromethazine hydrochloride — 6.25 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040649
Marketing start: Jun 4, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 0121-1070_acf1463f-bbbe-42e9-9b06-a306e95a4325SPL ID acf1463f-bbbe-42e9-9b06-a306e95a4325SPL set ID 1d47280d-28c9-4701-8c5f-a6e6b524083bRxCUI 991528UNII 9D2RTI9KYH, R61ZEH7I1I
Pharmacologic class: Phenothiazine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist

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

N400121107004 followed by a unit qualifier and the quantity

Package 00121-1070-04. 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 May 31, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-1070

What is NDC 0121-1070?: 0121-1070 is the product NDC for Promethazine DM, Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Promethazine DM (Promethazine Hydrochloride and Dextromethorphan Hydrobromide).
What is the active ingredient?: Dextromethorphan hydrobromide, Promethazine hydrochloride.
Who is the labeler?: PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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 DM?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 040649

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

FDA NDC Directory listings under ANDA 040649
Product	Strength	Form · route	Labeler	Product NDC
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral	Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	A-S Medication Solutions	50090-6585
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	ATLANTIC BIOLOGICALS CORP.	17856-0155
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	NuCare Pharmaceuticals,Inc.	68071-3551
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	Proficient Rx LP	71205-654