What is NDC 42571-346?

42571-346 is the product NDC for Caffeine Citrate, Caffeine citrate 60 mg/3mL solution, listed with the FDA by Micro Labs Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Caffeine Citrate?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Caffeine Citrate NDC 42571-346 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-346Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0346Add 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
42571-346-69	4257103466942571034669	10 VIAL in 1 BOX (42571-346-69) / 3 mL in 1 VIALMarketed from Feb 1, 2020
42571-346-96	4257103469642571034696	5 VIAL in 1 BOX (42571-346-96) / 3 mL in 1 VIALMarketed from Apr 23, 2026

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): Caffeine Citrate
Generic name (nonproprietary): caffeine citrate
Active ingredients: Caffeine citrate — 60 mg/3mL
Dosage form: Solution
Route: Oral
Labeler: Micro Labs LimitedNDC labeler code 42571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213202
Marketing start: Feb 1, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
Identifiers: Product ID 42571-346_57f8cddb-4aa6-756c-e063-6394a90ad218SPL ID 57f8cddb-4aa6-756c-e063-6394a90ad218SPL set ID db4477a3-b291-4b77-9eca-b7ba8f66b2beRxCUI 849928UNII U26EO4675QUPC 0342571346690
Pharmacologic class: Central Nervous System Stimulant; Methylxanthine

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

N442571034669 followed by a unit qualifier and the quantity

Package 42571-0346-69. 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 Aug 1, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Caffeine citrate is indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42571-346

What is NDC 42571-346?: 42571-346 is the product NDC for Caffeine Citrate, Caffeine citrate 60 mg/3mL solution, listed with the FDA by Micro Labs Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Caffeine Citrate.
What is the active ingredient?: Caffeine citrate.
Who is the labeler?: Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Caffeine Citrate?: 12 other product NDCs are listed under this name. See all Caffeine Citrate 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 Caffeine Citrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Caffeine Citrate	Caffeine citrate 20 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6267	00641-6267-10
Caffeine Citrate	Caffeine citrate 20 mg/mL	SolutionOral	Sun Pharmaceutical Industries, Inc.	47335-290	47335-0290-44
Caffeine Citrate	Caffeine citrate 60 mg/3mL	InjectionIntravenous	Armas Pharmaceuticals Inc.	72485-104	72485-0104-0172485-0104-10
Caffeine Citrate	Caffeine citrate 60 mg/3mL	Injection, SolutionIntramuscular, Intravenous	Micro Labs Limited	42571-244	42571-0244-98
Caffeine Citrate	Caffeine citrate 20 mg/mL	Injection, SolutionIntravenous	Eugia US LLC	55150-187	55150-0187-03
caffeine citrate	Caffeine citrate 20 mg/mL	InjectionIntravenous	Exela Pharma Sciences, LLC	51754-0500	51754-0500-01
Caffeine Citrate	Caffeine citrate 20 mg/mL	InjectionIntravenous	Sun Pharmaceutical Industries, Inc.	47335-289	47335-0289-27
caffeine citrate	Caffeine citrate 20 mg/mL	SolutionIntravenous	Sagent Pharmaceuticals	25021-601	25021-0601-03
caffeine citrate	Caffeine citrate 20 mg/mL	SolutionOral	Sagent Pharmaceuticals	25021-602	25021-0602-03
Caffeine Citrate	Caffeine citrate 20 mg/mL	SolutionOral	Fresenius Kabi USA, LLC	63323-406	63323-0406-03

All 13 Caffeine Citrate NDCs

Other NDCs under ANDA 213202

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

FDA NDC Directory listings under ANDA 213202
Product	Strength	Form · route	Labeler	Product NDC
Caffeine Citrate Oral Solutioncaffeine citrate	Caffeine citrate 60 mg/3mL	SolutionOral	Armas Pharmaceuticals Inc.	72485-110